ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
1999
Protocol ADD2002: A Multicenter, Open-Label, Uncontrolled, Dose Titration Study Of Five Oral Doses Of 1555U88 (1.25, 2,5, 5, 7,5, 10, 12.5 And 15 Mg Per Day) In The Treatment Of Attention Deficit/Hyperactivity Disorder In Children

2000
Protocol ADD20003: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Of Five Oral Doses Of 1555U88 (2.5, 5, 7.5, 10, And 15 Mg Per Day) In The Treatment Of Attention-Deficit/Hyperactivity Disorder In Children.

2000-2003
Phase III Open-Label Safety And Efficacy Study Of Atomoxetine In Outpatients With ADHD, 6 To 18 Years

2000-2001
Phase III Open-Label Safety And Efficacy Of Atomoxetine In Pediatric Outpatients (6 To 18 Years) With ADHD

2001
Protocol SLI381.305: An Open-Label, Multi-Center Study To Assess Tolerability, Effectiveness, And Quality Of Life Associated With The Use Of SLI381 (Adderall XRtm) In Children With Attention Deficit Hyperactivity Disorder (ADHD) In A Community Practice Setting.

2002-2003
Phase IIIA Randomized, Double-Blind Comaprison Of Atomoxetine Hydrochloride, Extended-Release Methylphenidate Hydrochloride (Concertatm), And Placebo In Pediatric Outpatients With DSM-IV Attention-Deficit Hyperactivity Disorder

2002-2003
A Randomized, Double-Blind, Placebo-Controlled Study of Atomoxetine Hydrochloride in Adolescents with Attention-Deficit/Hyperactivity Disorder and Comorbid Depressive Disorder

2003-2004
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Six-Week, Flexible, Oral-Dose Clinical Study Of Mecamylamine In The Treatment Of Attention Deficit Hyperactivity Disorder (ADHD)

2003-2006
An 8-Week, Open-Label Study To Characterize The Response To Modafinil (85-Mg Film-Coated Tablet) Treatment At Dosages Up To 425 Mg/Day In Children And Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) (With An Open-Ended Extension Period).

2003-2006
A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dosage (Up To 425 Mg/Day), Parallel-Group Study To Evaluate The Efficacy And Safety Of The Modafinil Film-Coated Tablet In Children And Adolescents With Attention-Deficit/Hyperactivity Disorder.

2003-2006
A 1-Year, Open-Label, Flexible-Dosage Study To Evaluate The Safety And Continued Efficacy Of Modafinil (Film-Coated Tablet Formulation) In Children And Adolescents With Attention-Deficit/Hyperactivity Disorder.

2004
A Phase IIIB Open-Label, Multi-Center Study To Assess Safety, Tolerability, And Effectiveness Associated With The Use Of Adderall Xr In Adults With Attention Deficit Hyperactivity Disorder And Evaluate An ADHD-Specific Novel Quality Of Life
Measure.

2004-2009
A Randomized, Double-Blind Comparison Of Placebo And Atomoxetine Hydrochloride Given Once A Day In Adults With ADHD: With A Secondary Examination Of Impact Of Treatment On Family Functioning.

2005
A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed To Evaluate The Safety And Efficacy Of Methylphenidate Transdermal System® (MTS) Vs. Concerta® In Pediatric Patients Aged
6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

2005
Protocol Number Spd485-303: Protocol Title: A Phase III, Multi-Center, Open-Label Study Of Methylphenidate Transdermal System® (MTS) In Pediatric Patients Aged 6-13 With Attention-Deficit/Hyperactivity Disorder (ADHD)

2005-2006
Phase IV Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults with ADHD and Comorbid Social Anxiety Disorder

2006
Efficacy, Safety And Tolerability Of Zolpidem In The Treatment Of Children Aged 6 To 17 Years With ADHD-Associated With Insomnia. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

2006-2007
A 6-Week, Double-Blind, Placebo-Controlled, Parallel-Group Randomized-Withdrawal Study To Evaluate The Continued Efficacy Of Modafinil Treatment At Dosages Up To 425 Mg/Day In Patients With Attention-Deficit/Hyperactivity Disorder Who Are Responders To Modafinil Treatment, Followed By A 12-Month Open-Label Extension Period

2006-2007
A Phase IV, Multi-Center, Open-Label Study Of Daytrana™, Methylphenidate Transdermal System (MTS) To Characterize The Dermal Reactions In Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD).

2006-2007
A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating The Efficacy And Safety Of Spd503 In Children Aged 6-12 With Symptoms Of Oppositionality And A Diagnosis Of Attention-Deficit/Hyperactivity Disorder.

2007
Evaluation of the Safety, Tolerability and Pharmacokinetic Profile of ABT-089 Following Administration of Escalating, Single Doses in Pediatric Subjects with Attention Deficit Hyperactivity Disorder (ADHD)

2007-2008
A Phase III, Dose-Response Evaluation of the Efficacy and Safety of Clonicel (Clonidine HCl Sustained Release) Vs. Placebo in the Treatment of Children and Adolescents with Attention Deficit Hyperactivity Disorder (ADHD)

2007-2008
A Phase IIIB, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed To Evaluate the Efficacy and Safety of Methylphenidate Transdermal System (MTS) In Adolescents Aged 13-17 Years with Attention-Deficit/Hyperactivity Disorder (ADHD)

2007-2008
A Prospective, Open-Label, Multi-Center, Dose-Optimization Study Evaluating The Efficacy, Safety, And Tolerability Of Vyvanse 20-70 Mg In Children Aged 6-12 Diagnosed With ADHD

2007-2009
A Phase IIIB, Long-Term, Open-Label, Multi-Center, Extension Study Designed To Evaluate The Safety And Efficacy Of Methylphenidate Transdermal System (MTS) In Adolescents Aged 13-17 Years With Attention Deficit/Hyperactivity Disorder (ADHD)

2007-2009
An Open-Label, Chronic Exposure Evaluation of the Safety of Clonicel (Clonidine HCl Sustained Release) In the Treatment of Children and Adolescents with Attention Deficit Hyperactivity Disorder (ADHD)

2007-2010
A Double-Blind Study Of Atomoxetine Hydrochloride Versus Placebo For The Treatment Of ADHD In Young Adults With An Assessment Of Associated Functional Outcomes

2008-2009
A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-Dose Titration, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) In Adolescents Aged 13 – 17 with Attention-Deficit/Hyperactivity Disorder (ADHD)

2008
Best Estimate Diagnosis Used To Evaluate Eeg In Association With ADHD In A Multi-Site, Clinical Sample Of Children And Adolescents

2008-2009
A Safety, Tolerability, Pharmacokinetic And Pharmacodynamic Evaluation Of Single Oral Doses Of Eszopiclone In Adolescents 12 To 17 Years Of Age With Attention Deficit Hyperactivity Disorder And Insomnia (Study #1)

2008-2009
A Safety, Tolerability, Pharmacokinetic And Pharmacodynamic Evaluation Of Single Oral Doses Of Eszopiclone In Children 6 To 11 Years Of Age With Attention Deficit Hyperactivity Disorder And Insomnia (Study #2)

2008-2009
A Randomized, Multicenter, Parallel Group, Dose-Ranging Study To Evaluate the Safety and Tolerability of Spn-810 in Children with Attention-Deficit/Hyperactivity Disorder (ADHD) and Persistent Serious Conduct Problems

2008 – 2010
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of Spd503 in Combination with Psychostimulants in Children and Adolescents Aged 6-17 Years with A Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

2008 – 2010
A Phase III, Open-Label, Extension, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-Dose Titration, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) In Adolescents Aged 13 – 17 with Attention-Deficit/Hyperactivity Disorder (ADHD)

2009 – 2010
A Phase 3, Double-Blind, Randomized, Multicenter, Placebo Controlled, Dose Optimization Study Evaluating The Tolerability And Efficacy Of AM And PM Once Daily Dosing With Extended-Release Guanfacine Hydrochloride In Children Aged 6-12 With A Diagnosis Of Attention-Deficit/Hyperactivity Disorder

2009-2010
A Fixed-Dose, Randomized, Double-Blind, Placebo-Controlled Study Of LY2216684 In Pediatric Patients With Attention Deficit/Hyperactivity Disorder

2009-2011
A Long-Term, Open-Label, Safety Study of Eszopiclone in Children (6 To 11 Years) and Adolescents (12 To 17 Years) With Attention-Deficit/Hyperactivity Disorder-Associated Insomnia

2009 – 2011
A Randomized, Placebo-Controlled, Double-Blind, Fixed-Dose Study Of The Efficacy And Safety Of Eszopiclone In Children (6 To 11 Years) And Adolescents (12 To 17 Years) With Attention-Deficit/Hyperactivity Disorder-Associated Insomnia

2010 – 2012
A Phase 3, Double-Blind, Placebo-Controlled, Multicentre, Randomised-Withdrawal, Long-Term Maintenance of Efficacy and Safety Study of Extended-Release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 with Attention-Deficit/Hyperactivity Disorder

2010 – 2012
A Phase 3B, Double-Blind, Randomised, Active-Controlled, Parallel Group Study To Compare The Time To Response Of Lisdexamfetamine Dimesylate To Atomoxetine Hydrochloride In Children And Adolescents Aged 6 17 Years With Attention Deficit/Hyperactivity Disorder (ADHD) Who Have Had An Inadequate Response To Methylphenidate Therapy.

2010 – 2014
A Phase 3, Double-Blind, Randomized, Multi-Center, Placebo-Controlled, Dose-Optimization Study Evaluating The Safety, Efficacy, And Tolerability Of Once-Daily Dosing With Extended-Release Guanfacine Hydrochloride In Adolescents Aged 13-17 Years Diagnosed With Attention-Deficit/Hyperactivity Disorder (ADHD)

2011 – 2012
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Molindone Hydrochloride Extended-Release Tablets as Adjunctive Therapy in Children with Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD)

2011 – 2012
810p203: Open-Label Extension Study to Evaluate the Safety of Molindine Hydrochloride Extended-Release Tablets as Adjunctive Therapy in Children with Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD)

2011 – 2013
A 40-week, Phase 4m Double-blind, Placebo-controlled, Multicenter, Randomized-withdrawal Study to Evaluate the Long-term Efficacy and Safety of KAPVAYTM (Clonidine Hydrochloride) Extended-Release in Children and Adolescents with Attention Deficit Hyperactivity Disorder

2012 – 2014
A Phase 4, Randomized, Double-Blind, Multicenter, Parallel-Group, Active-Controlled, Dose-Optimization Safety And Efficacy Study Of SPD489 (Vyvanse®) Compared With OROS-MPH (Concerta®) With A Placebo Reference Arm, In Adolescents Aged 13-17 Years With ADHD.

AUTISM
2002
Protocol Rg1068-04-02: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Mutliple Dose Study To Assess The Efficacy, Safety, And Tolerability Of RG1068 (Synthetic Human Secretin) In Children With Autism.

2002
Protocol 1068-06: Open Label Extension For The Treatment Of Children Previously Enrolled In Repligen Protocol RG1068-03 Or RG1068-04

2005-2006
Oral Human Immunoglobulin In Autism: A Randomized Phase II Trial To Evaluate The Safety And Efficacy Of Oral Human Immunoglobulin In The Treatment Of Gastrointestinal Dysfunction Associated With Autistic Disorder In Pediatric Patients From 2 To 18 Years Of Age

2006-2008
A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study Of Aripiprazole Flexibility Dosed In The Treatment Of Children And Adolescents With Autistic Disorder

2006-2008
A 52-Week, Open-Label, Multicenter Study of the Safety and Tolerability of Aripiprazole Flexibly Dosed In the Treatment of Children and Adolescents with Autistic Disorder

2010-2012
Safety And Efficacy Of Aripiprazole In The Long-Term Maintenance Treatment Of Pediatric Patients With Irritability Associated With Autistic Disorder.

2012 – 2013
An Open-Label Study of the Safety and Tolerability of Memantine in Pediatric Patients with Autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

2012 – 2014
An Open-Label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients with Autism, Asperger’s Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

2012 – 2014
A Double-Blind Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients with Autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated With Memantine

BIPOLAR DISORDER
2003-2004
An Open-Label Study Of Tolerability, Clinical Response And Satisfaction In Adult Bipolar I Subjects Optimizing Initiation Of Therapy Using Administration Of Dermatological Precautions And Lamictal Titration Packs

2005
An Open-Label Study To Evaluate The Safety Of Depakote® ER In The Treatment Of Mania Associated With Bipolar I Disorder In Children And Adolescents.

2005-2007
A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase III Comparison Of The Efficacy And Safety Of Quetiapine Fumarate To Placebo When Used As Adjunct To Mood Stablizers In The Maintenance Of Bipolar I Disorder In Adult Patients

2006
A Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, Phase III Study To Compare The Efficacy And Safety Of Quetiapine Fumarate (Seroquel) Versus Placebo As Adjunct Therapy With Mood Stabilizers (Lithium Or Divalproex) For The Treatment Of Alcohol Dependence In Patients With Bipolar I Disorder

2006-2007
Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase III Study Of The Efficacy And Safety Of Quetiapine Fumarate And Lithium As Monotherapy For Up To 104 Weeks Maintenance Treatment Of Bipolar I Disorder In Adult Patients

2006-2008
A Phase IV, Multi-Center, Open-Label, Safety and Effectiveness Study of Extended Release Carbamazepine in the Treatment of Mania in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder.

2006-2008
A Six-Week, Randomized, Double-Blind, Multicenter, Fixed-Flexible Dose, Placebo-Controlled Study Evaluating The Efficacy And Safety Of Oral Ziprasidone In Outpatients With Bipolar I Depression.

2008-2009
The Evaluation of Lamictal™ As an Add-On Treatment for Bipolar I Disorder In Children and Adolescents, 10 To 17 Years of Age

2008-2010
An 8-Week, Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel®) Extended-Release in Children and Adolescent Subjects with Bipolar Depression

2009
Study To Assess The Safety And Efficacy Of Olanzapine And Fluoxetine Combination Versus Placebo In Patients Ages 10 To 17 In The Treatment Of Major Depressive Episodes Associated With Bipolar I Disorder

2010 – 2012
A 6 Month, Open-Label, Flexible-Dosage (150 To 200 Mg/Day) Extension Study Of The Safety And Efficacy Of Armodafinil Treatment As Adjunctive Therapy In Adults With Major Depression Associated With Bipolar I Disorder

2010-2012
A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study To
Evaluate The Efficacy And Safety Of Armodafinil Treatment (150 And 200 Mg/Day) As Adjunctive Therapy In Adults With Major Depression Associated With Bipolar I Disorder

2011 – 2013
Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder

2011 – 2013
A 26-Week Open-Label, Flexible-Dose Trial of Asenapine Extension Treatment to P06107 in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I

DEPRESSION

1998
Protocol M/2020/0047: Reboxetine, Placebo, And Paroxetine Comparison In Patients With Major Depressive Disorder.

1999
Protocol 950E-CNS-0005-087: Open-Label Reboxetine Continuation Therapy.

2002
Protocol 134-019: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Safety And Efficacy Trial Of Org 33062 Er In Outpatient Children And Adolescents With Major Depressive Disorder

2003
Protocol 134-507: Open-Label Extension Trial In Children And Adolescents With Major Depressive Disorder Who Participated In One Of The Short-Term ORG 33062 ER Safety And Efficacy Trials.

2004-2005
RIS-DEP 401: A Double-Blind, Randomized, Prospective Trial To Evaluate Augmentation Of Citalopram With Risperidone Versus Placebo In Patients With Major Depressive Disorder Resistant To Citalopram And Prior Antidepressant

2005-2007
A Multi-Centre, Double-Blind, Randomised-Withdrawal, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR™) As Monotherapy in the Maintenance Treatment of Patients with Major Depressive Disorder Following an Open-Label Stabilisation Period (Amethyst Study)

2006-2007
A Comparison Of Zolpidem Tartrate Extended-Release Vs. Placebo In The Treatment Of Insomnia Associated With Newly Diagnosed Major Depressive Disorder (MDD) Or Untreated MDD Relapse, When Used Concomitantly With Escitalopram

2006-2007
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study Of The Efficacy And Safety Of Quetiapine Fumarate Sustained Release (Seroquel SR ™) In Combination With An Antidepressant In The Treatment Of Patients With Major Depressive Disorder With Inadequate Response To An Antidepressant Treatment (Pearl Study)

2006 – 2008
A Multicenter, Randomized, 8-Week Double-Blind Acute Phase Followed By A 6-Month Continuation Phase (Open-Label Or Double-Blind) Study To Evaluate The Efficacy, Safety, And Tolerability Of DVS SR Versus Escitalopram In Postmenopausal Women
With Major Depressive Disorder

2007
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study Of The Efficacy And Safety Of Quetiapine Fumarate Sustained Release (Seroquel SRtm) As Mono-Therapy In The Treatment Of Elderly Patients With Major Depressive Disorder (Sapphire Study)

2007
A Randomized, Double-Blind, Two-Arm Study Comparing the Efficacy and Safety of Trazodone Contramid OAD and Placebo in the Treatment of Unipolar Major Depressive Disorder

2007-2008
A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study Of The Long-Term Efficacy, Tolerability And Safety Of Agomelatine 25 And 50 Mg In The Prevention Of Relapse Of Major Depressive Disorder (MDD) Following Open-Label Treatment Of 16-24 Weeks

2007-2008
An Open-Label Study Of Tolerability, Safety, And Pharmacokinetics Of Duloxetine In The Treatment Of Children And Adolescents With Major Depressive Disorder

2007-2009
A 12 Week, Randomized, Open-Label Trial of Duloxetine versus Generic SSRIs in the Treatment of a Severe Depressive Episode

2007-2009
A One Year Open Label Study Assessing The Safety And Tolerability Of Vilazodone In Patients With Major Depressive Disorder/CLDA-07-DP-04

2007-2009
A Phase IV, Double-Blind, Placebo-Controlled, Randomized, Flexible-Dose Study of the Safety and Efficacy of Emsam in Adolescents with Major Depression

2008 – 2009
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Luaa21004 in Acute Treatment of Adults with Major Depressive Disorder

2008 – 2010
A Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Luaa21004 in Subjects with Major Depressive Disorder

2008-2010
A Phase IIB, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Efficacy And Safety Study Of Adjunctive AZD6765 In Subjects With Severe Major Depressive Disorder (MDD) And A History Of Poor Response To Antidepressants

2008 – 2011
A Double-Blind, Efficacy And Safety Study Of Duloxetine Versus Placebo In The Treatment Of Children And Adolescents With Major Depressive Disorder

2009
A Double-Blind, Randomized, Placebo-Controlled Study Examining, The Safety, Efficacy, And Tolerability Of SEP-225289 In Subjects With Major Depressive Disorder (Including Atypical And Melancholic Features)

2009 – 2011
A Double-Blind, Placebo-Controlled, Flexible-Dose Study Of F2695 SR In Patients With Major Depressive Disorder

2010
A Long-Term, Open-Label Extension Study Of F2695 SR In Adult Patients With Major Depressive Disorder

2010 – 2011
A Double-Blind, Efficacy and Safety Study of Duloxetine versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder

2010-2011
A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients with Major Depressive Disorder

2010-2011
A Multicenter, 52-week, Open-label Study to Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients with Major Depressive Disorder. Protocol No. 31-08-257

2010 – 2012
A Long-Term, Open-Label Extension Study of F2695 SR in Adult Patients with Major Depressive Disorder

2010 – 2012
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III, Efficacy And Safety Study Of 3 Fixed Dose Groups Of TC-5214 (S-Mecamylamine) As An Adjunct To An Antidepressant In Patients With Major Depressive Disorder Who Exhibit An Inadequate Response To Antidepressant Therapy.

2010 – 2012
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III, Long-Term Safety And Tolerability Study Of TC-5214 (S Mecamylamine) As An Adjunct To An Antidepressant In Patients With Major Depressive Disorder Who Exhibit An Inadequate Response To Antidepressant Therapy.

2010 – 2012
Long-Term, Open-Label, Safety Study of LY2216684 12 To 18 Mg Once Daily as Adjunctive Treatment for Patients with Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment

2010 – 2012
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Duloxetine-Referenced, Fixed-Dose Study Comparing The Efficacy And Safety Of 2 Doses (15 And 20 Mg) Of Lu Aa21004 In Acute Treatment Of Adults With Major Depressive Disorder

2010 – 2014
A Phase 3, Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu Aa21004 (15 And 20 Mg) In Subjects with Major Depressive Disorder

2011-2012
A Double-Blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran SR in Patients with Major Depressive Disorder

2011-2013
LY2216684 Compared To Placebo As Adjunctive Therapy To SSRI In The Prevention Of Symptom Re-Emergence In Major Depressive Disorder

2011 – 2013
A Double-Blind, Placebo- Controlled, Study of Cariprazine (RGH-188) As Adjunctive Therapy in Major Depressive Disorder

2011 – 2013 (Gainesville and Lake City)
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase IIB Efficacy And Safety Study Of Adjunctive AZD6765 In Patients With Major Depressive Disorder (MDD) And A History Of Inadequate Response To Antidepressants

2011 – 2013
A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Flexible-Dose Study Evaluating The Effect Of Lu Aa21004 Vs. Escitalopram On Sexual Functioning In Adults With Well-Treated Major Depressive Disorder Experiencing Selective Serotonin Reuptake Inhibitor–Induced Sexual Dysfunction

2011 – 2014 (Lake City, FL and Gainesville, FL)
A Phase 3, Open-Label, Multicenter, 12-Month Extension Safety And Tolerability Study Of SPD489 In Combination With An Antidepressant In The Treatment Of Adults With Major Depressive Disorder With Residual Symptoms Or Inadequate Response Following Treatment With An Antidepressant

2011 – 2014 (Lake City, FL and Gainesville, FL)
A Phase 2, Multicenter, Double-Blind, Parallel-Group, Randomized, Placebo-Controlled, Forced-Dose Titration, Dose-Ranging Efficacy And Safety Study Of SPD489 In Combination With An Antidepressant In The Treatment Of Adults With Major Depressive Disorder With Inadequate Response To Prospective Treatment With An Antidepressant.

2012 – 2014
Phase 2, Double-Blind, Placebo Controlled, Randomized Withdrawal, Parallel Efficacy and Safety Study of GLYX-13 in Subjects with Inadequate/Partial Response to Antidepressants during the Current Episode of Major Depressive Disorder

2013 – 2014
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-GFroup Study to Investigate the Efficacy and Safety of RO4995819 Versus Placebo, as Adjunctive Therapy in Patients with Major Depressive Disorder Having Inadequate Response to Ongoing Antidepressant Therapy

DOWN SYNDROME
2008
A 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Donepezil Hydrochloride (Aricept®) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17

2008-2009
A 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Donepezil Hydrochloride (Aricept®) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10

EATING DISORDERS
2002-2003
Protocol CAPSS-169: The Effect Of Ortho Tri-Cyclen On Bone Mineral Density In Pediatric Subjects With Anorexia Nervosa: A Double-Blind, Placebo-Controlled Study.

FIBROMYALGIA
2010 – 2012
A Multicenter, Open-Label, 52-Week Extension Study to Evaluate the Safety and Efficacy of Milnacipran in Pediatric Patients with Primary Fibromyalgia

2011 – 2012
A Multicenter, Randomized, Double-Blind, Placebo Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients with Primary Fibromyalgia

GENERALIZED ANXIETY DISORDER(GAD)
2004-2005
RIS-ANX 301: A Double-Blind, Randomized, Prospective, Study to Evaluate Adjunctive Risperidone versus Adjunctive Placebo in Generalized Anxiety Disorder Sub-Optimally Responsive To Standard Psychotropic Therapy.

2005-2006
A Randomized, Double-Blind, Placebo And Active Comparator Controlled, Parallel-Group Safety And Efficacy Study Of Oros® Alprazolam In Adults With Generalized Anxiety Disorder (GAD) (2005-2006)

2006
A Long-Term, Open-Label, Safety And Efficacy Study Of Oros® Alprazolam In Adults With Generalized Anxiety Disorder (GAD)

2006
The Efficacy Of Eszopiclone 3 Mg As Adjunctive Therapy In Subjects With Insomnia Related To Generalized Anxiety Disorder (GAD).

2006-2007
A Multi-Centre, Double-Blind, Randomised-Withdrawal, Parallel-Group, Placebo-Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR™) As Monotherapy in the Maintenance Treatment of Patients with Generalised Anxiety Disorder Following an Open-Label Stabilisation Period (Platinum Study)

2006-2007
A Comparison Of Zolpidem Tartrate Extended-Release Vs. Placebo In The Treatment Of Insomnia Associated With Generalized Anxiety Disorder (GAD) When Used Concomitantly With Escitalopram

2007-2009
A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study Examining The Efficacy And Safety Of Sep-225441 In Subjects With Generalized Anxiety Disorder

2007
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase
III Study Of The Efficacy And Safety Of Quetiapine Fumarate Sustained Release (Seroquel SRtm) As Mono-Therapy In The Treatment Of Elderly Patients With Generalised Anxiety Disorder (Chromium Study)

2008
A Multi-Center Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized Anxiety Disorder

2008-2009
A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase II Study of 2 Oral Dose Groups Of AZD7325, With a Lorazepam Arm, In Subjects with Generalized Anxiety Disorder (GAD)

2011 – 2014
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Safety And Tolerability Of SPD503 In Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), Or Social Phobia (SOP)

MIGRAINE
2002-2003
Protocol SUM30045: A Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate two Dose Levels (5 Mg And 20 Mg) Of Sumatriptan Nasal Spray In The Acute Treatment Of Single Migraine Attack In Adolescent Migraineurs (12-17 Years Of Age

2005
Divalproex Sodium Extended-Release Tables For Migraine Prophylaxis in Adolescents: An Open-Label, Long-Term Safety Study.

2005-2006
Protocol CAPSS 381: Topiramate Intervention To Prevent Transformation Of Episodic Migraine.

2008-2010
A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study To Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents

2009 – 2010
A Worldwide, Randomized, Double Blind, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents

2009 – 2010
A Worldwide, Open Label, Clinical Trial to Examine the Long Term Safety and Tolerability of Rizatriptan in Pediatric Migraineurs for the Treatment of Migraine With or Without Aura

OPIATE DEPENDENCE
2013 – 2014 (LAKE CITY)
Induction, Stabilization, Adherence And Retention Trial (ISTART) -A Randomized Non-Inferiority Multicenter Study To Assess Early Treatment Efficacy Of OX219 Versus Suboxone® Film And To Explore Switching Between Treatments

POST TRAUMATIC STRESS DISORDER (PTSD)
2011 – 2013
Single Site, Open Label Pilot Study of PRX-03140 to Assess Safety for Use in Adults with Post Traumatic Stress Disorder

RESTLESS LEG SYNDROME
2006-2007
An Open-Label Clinical Study to Investigate Pharmacokinetics (PK) Of Different Doses (0.125 Mg, 0.25 Mg, 0.5 Mg) Of Pramipexole Administered Once Daily Orally In Pediatric Patients Who Are Individually Optimized To Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)

SEIZURE DISORDER
2010 – 2012
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin CR as Adjunctive Therapy in Adult Patients with Partial Onset Seizures.

2010 – 2012
An Open-Label Multicenter Extension Study to Determine Long Term Safety and Efficacy of Pregabalin (Lyrica) As Monotherapy in Patients with Partial Seizures

2010 – 2012
A Double-Blind, Randomized, Multicenter Efficacy and Safety Study of Pregabalin (Lyrica) As Monotherapy in Patients with Partial Seizures

2010 – 2012
A Historical-Controlled, Multicenter, Double-Blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400mg/Day Monotherapy in Subjects with Partial-Onset Seizures (Protocol Number SP902)

2010 – 2013
A Multicenter, Open-Label Extension Trial to Assess the Long-Term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-Onset Seizures (Protocol Number SP904)

2010-2011
BIA-2093-304: Efficacy And Safety Of Eslicarbazepine Acetate (BIA 2-093) As Adjunctive Therapy For Refractory Partial Seizures In A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre Clinical Trial

2010 – 2013
A Randomized, Multicenter, Double-Blind, Placebo–Controlled, Parallel-Group, Phase 3 Study To Evaluate The Efficacy And Safety Of Usl255 As Adjunctive Therapy In Patients With Refractory Partial-Onset Seizures. P09-004

2010 – 2013
Open-Label Extension Study To Evaluate The Safety Of Usl255 As Adjunctive Therapy In Patients With Refractory Partial-Onset Seizures Who Had Participated In P09-004, A Randomized, Multicenter, Double-Blind, Placebo–Controlled, Parallel-Group, Phase 3 Study. P09-005

SEXUAL DYSFUNCTION
2009-2011
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Phase III Safety Trial of Flibanserin Tablets (100 Milligrams Daily) In Women Taking A Selective Serotonin or Serotonin-Norepinephrine Reuptake Inhibitor with Decreased Sexual Desire and Distress

SLEEP DISORDER
2001-2003
Phase III Placebo-Controlled Study Of The Effects Of Atomoxetine Hydrochloride On Bladder Control In Children With Nocturnal Enuresis

2001-2006
Plase III Long-Term, Open-Label Safety Study Of Atomoxetine Hydrochloride In Patients 6 Years And Older

2005
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Assess The Efficacy And Safety Of Provigil® (Modafinil) Treatment (100, 200, And 400 Mg/Day) In Children And Adolescents With Excessive Sleepiness Associated With Narcolepsy.

2005-2006
A 1-Year Open-Label, Flexible-Dosage Extension Study To Assess The Safety And Continued Effectiveness Of Provigil® (Modafinil) Treatment In Children And Adolescents With Excessive Sleepiness Associated With Narcolepsy Or Obstructive Sleep Apnea/Hypopnea Syndrome.

2009-2013
Single Dose, Open Label Safety, Tolerability, Pharmacokinetic And Pharmacodynamic Evaluation Of Three Different Eplivanserin Doses In Children Aged 6-17 Years With Insomnia Of Various Origins

VACCINE STUDIES
2009 – 2012
A Phase 1/2A, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study To Evaluate The Safety, Tolerability, Immunogenicity And Vaccine-Like Viral Shedding Of MEDI-534, A Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) And Parainfluenza Virus Type 3 (PIV3), In Healthy 6 To

2012 – 2014
A Phase III Double-Blind, Randomized, Multicenter, Controlled Study To Evaluate The Safety, Tolerability, And Immunogenicity Of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made With An Alternative Manufacturing Process (AMP)

SCALE VALIDATION STUDY

Sheehan Disability Scale: Psychometric Validation in Patients with Bipolar Disorder

CHILD AND ADOLESCENT PSYCHIATRY STUDY

Clinical Research Participation between Duke University and Sarkis Clinical Trials Through the National Institute of Mental Health

OTHER
2001
Phase III Safety And Efficacy Of Atomoxetine Or Atomoxetine And Fluoxetine In The Treatment Of Mixed Attentional And Affective Disorders

2001
Protocol CTN:950ECNSO323-001: Pharmacogenomics Blood Sampling Protocol (Reboxetine).

2006-2008
A Three-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating The Efficacy And Safety Of Add-On Oral Ziprasidone In Subjects With Acute Mania Treated With Lithium Or Divalproex.

2007
Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers