Information for Sponsors : Past Trials

ADHD

An 8-Week, Open-Label Study to Characterize the Response to study drug(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)

"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 an Investigational Film-Coated Tablet in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder."

"A 1-Year, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Continued Efficacy of an investigational drug (Film-Coated Tablet Formulation) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder."

A Randomized, Double-Blind Comparison of Investigational drug, Extended-Release Methylphenidate Hydrochloride and Placebo in Pediatric Outpatients with DSM-IV Attention-Deficit Hyperactivity Disorder

A Randoomized, Double-Blind, Placebo-Controlled Study of an Investigational drug in Adolescents with Attention-Deficit/Hyperactivity Disorder and Comorbid Depressive Disorder

Phase III Open-Label Safety and Efficacy Study of an investigational medication in Outpatients with ADHD, 6 to 18 Years

Phase III Open-Label Safety and Efficacy of an investigational medication in Pediatric Outpatients (6 to 18 Years) with ADHD

A Phase III, Multi-Center, Open-label Study of an investigational medication in Pediatric Patients aged 6-13 with Attention-Deficit/Hyperactivity Disorder(ADHD)

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of Five Oral Doses of investigational drug (2.5, 5, 7.5, 10, and 1"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." 5 mg per day) in the Treatment of Attention-Deficit/Hyperactivity Disorder in Children.

An Open-Label, Multi-Center Study to Assess Tolerability, Effectiveness, and Quality of Life Associated with the Use of an investigational medication in Children with Attention Deficit Hyperactivity Disorder (ADHD) in a Community Practice Setting

Open-Label Study Drug Continuation Therapy

Pharmacogenomics Blood Sampling Protocol

An 8-Week, Open-Label Study to Characterize the Response to an Investigational Medication(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) (2005-2006)

A Randomized, Double-Blind Comparison of Placebo and Investigational drug given once a day in Adults with Attention-Deficit/Hyperactivity Disorder with an Examination of Impact of Treatment on Family Functioning

A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Study Drug vs. Concerta® in Pediatric Patients aged 6-12 with Attention-Deficit/Hyperactivity Disorder (ADHD)

A Phase III, Multi-Center, Open-label, Study of and investigational drug in Pediatric Patients aged 6-13 with Attention-Deficit/Hyperactivity Disorder (ADHD).

"A 1-Year, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Continued Efficacy of an investigational drug (Film-Coated Tablet Formulation) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder." (11/2003-Present)

"A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Six-Week, Flexible, Oral-Dose Clinical Study of an investigational drug in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)." (11/2003-Present)

"A Phase IIIb Open-Label, Multi-Center Study to Assess Safety, Tolerability, and Effectiveness Associated with the use of an investigational drug in Adults with Attention Deficit Hyperactivity Disorder and Evaluate an ADHD-Specific Novel Quality of Life Measure." (11/2003-Present)

A 6-week, Double-Blind, Placebo-Controlled, Parallel-Group Randomized-Withdraw Study to Evaluate the Continued Efficacy of study drug 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.Phase III Safety and Efficacy of study drug or study drug and Fluoxetine in the Treatment of Mixed Attentional and Affective DisordersADHD W/SOCIAL ANXIETY DISORDER

A Double-Blind Placebo Controlled Study of an investigational drug in the Treatment of Adults with ADHD and Comorbid Social Anxiety Disorder. (2005-2006)

ANOREXIA NERVOSA

The Effect of study medication on Bone Mineral Density in Pediatric Subjects with Anorexia Nervosa: A Double-Blind, Placebo-Controlled Study.

AUTISM

A randomized phase II trial to evaluate the safety and efficacy of study medication in the treatment of gastrointestinal dysfunction associated with Autistic Disorder in pediatric patients from 2 to 18 years of age.

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Mutliple Dose Study to Assess the Efficacy, Safety, and Tolerability of study drug in Children with Autism with Open Label Extension for the Treatment of Children Previously Enrolled

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of an investigational medication Flexibly Dosed in the Treatment of Children and Adolescents with Autistic Disorder.

A 52-Week, Open-Label, Multicenter Study of the Safety and Tolerability of an investigational medication Flexibility Dosed in the Treatment of Children and Adolescents with Autistic Disorder.BIPOLAR I DISORDER

"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 study medication Titration Packs."

"A Six-Week, Randomized, Double-Blind, Multicenter, Fixed-Flexible Dose, Placebo-Controlled Study Evaluating the Efficacy and Safety of an investigational medication in Outpatients with Bipolar I Depression."

An Open-Label Study to Evaluate the Safety of an investigational medication in the Treatment of Mania Associated with Bipolar I Disorder in Children and Adolescents.

"A Multi-center, Randomized, Parallel-group, Double-blind, Phase III Comparison of the Efficacy and Safety of study drug (oral tablets 400 mg to 800 mg daily in divided doses) to Placebo When Used as Adjunct to Mood Stabilizers in the Maintenance of Bipolar I Disorder in Adult Patients.""A Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study of the Efficacy and Safety of an investigational medication and Lithium as Monotherapy for up to 104 weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients."

"A Phase IV, Multi-Center, Open-Label, Safety and Effectiveness Study of an investigational medication in the Treatment of Mania in Children and Adolescents Aged 10-17 years with Acute Manic or Mixed Bipolar I Disorder.""A Three-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Add-On study drug in Subjects with Acute Mania Treated with Lithium or Divalproex."BIPOLAR I DISORDER W/ALOCOHOLISM

"A Multi-center, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, Phase III Study to Compare the Efficacy and Safety of study drug versus Placebo as Adjunct Therapy with Mood Stabilizers for the treatment of Alcohol Dependence in Patients with Bipolar I Disorder."ENURESIS

Phase III Placebo-Controlled Study of the Effects of an investigational drug on Bladder Control in Children with Nocturnal EnuresisGENERALIZED ANXIETY DISORDER

A Long-Term, Open-Label, Safety and Efficacy Study of an investigational drug in Adults with Generalized Anxiety Disorder (GAD) (2006)

A Randomized, Double-Blind, Placebo and Active Comparator Controlled, Parallel-Group Safety and Efficacy Study of an investigational medication in Adults with Generalized Anxiety Disorder (GAD) (2005-2006)

A Long-Term, Open-Label, Safety and Efficacy Study of an investigational medication in Adults with Generalized Anxiety Disorder (GAD) (2006)

A double-blind, randomized, prospective, study to evaluate an investigational medication versus adjunctive placebo in Generalized Anxiety Disorder sub-optimally responsive to standard psychotropic therapy.

"A Multi-centre, Double-blind, Randomised-Withdrawal, Parallel-group, Placebo-controlled Phase III Study of the Efficacy and Safety of an investigational medication as Monotherapy in the Maintenance Treatment of Patients with Generalised Anxiety Disorder Following an Open-Label Stabilisation Period."GENERALIZED ANXIETY DISORDER W/INSOMNIA

The Efficacy of an investigational medication as Adjunctive Therapy in Subjects with Insomnia Related to Generalized Anxiety Disorder (GAD)

"A Comparison Of Study Drug Vs. Placebo In The Treatment Of Insomnia Associated With Generalized Anxiety Disorder (GAD) When Used Concomitantly With Escitalopram."

MAJOR DEPRESSIVE DISORDER

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Safety and Efficacy Trial of a study drug in Outpatient Children and Adolescents with Major Depressive DisorderStudy drug, Placebo, and Paroxetine Comparison in Patients with Major Depressive DisorderA double-blind, randomized, prospective trial to evaluate augmentation of citalopram with study drug versus placebo in patients with Major Depressive Disorder resistant to citalopram and prior antidepressant

Open-Label extension trial in children and adolescents with major depressive disorder who participated in one of the short-term investigational medication safety and efficacy trials." (2003)"A Multi-centre, Double-Blind, Randomised-withdrawl, Parallel-group, Placebo-controlled Phase III Study of the Efficacy and Safety of an investigational medication as Monotherapy in the Maintenance Treatment of Patients with Major Depressive Disorder Following an Open-Label Stabilisation Period.""A Comparison of an investigational medication Vs. Placebo in the Treatment of Insomnia Associated With Newly Diagnosed Major Depressive Disorder (MDD) Or Untreated MDD Relapse, When used Concomitantly with Escitalopram ("Protocol"), to be conducted by Investigator.

Lilly’s Emotional and Physical Symptoms Study (LEAPS)MIGRAINE

A Double-Blind, Placebo-Controlled, Parallel Group Study to EvaluateTwo Dose Levels (5MG and 20 MG) of an investigational Nasal Spray in the Acute Treatment of Single Migraine Attack in Adolescent Migraineurs (12-17 Years of Age)A study drug intervention to prevent transformation of episodic migraine(Phase IV) (2005-2006)

"A Phase III, Open-Label, Multi-Center, Long-term Safety Study of investigational Extended-Release Tablets for Migraine Prophylaxis in Adolescents."NARCOLEPSY

"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of an investigational drug (100, 200, and 400 mg/day) in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy" SLEEP APNEA

"A 1-Year Open-Label, Flexible-Dosage Extension Study to Assess the Safety and Continued Effectiveness of an investigational medication in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome"

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