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Psychiatry Clinical Trials

OSU Harding Hospital and the OSU Department of Psychiatry are committed to finding new treatments to decrease morbidity and mortality and improve the quality of life of patients with mental and behavioral disorders.

The clinical trials program at OSU Harding Hospital and the OSU Department of Psychiatry is one way to determine whether new treatments are safe and effective. The trials encompass agents that are in various phases of development across numerous diagnostic categories. Our goal is to ultimately establish new therapies to minimize the distress experienced by patients with an array of mental disorders.

Below is a list of ongoing and currently-enrolling clinical trials being conducted at OSU Harding Hospital and the OSU Department of Psychiatry as a part of a larger research program that includes pharmacology, genetics and imaging. These clinical trials, in adults and children, encompass diagnostic categories such as Bipolar Disorders, Depressive Disorders, Anxiety Disorders, and Attention Deficit and Hyperactivity Disorders (ADHD).

Anxiety:

Protocol A5361017: “A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group, 10-Week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder.”

Research study of an investigational medication for generalized anxiety disorder in adults ages 18-65.

Protocol A5361022:  "A Phase 3, 52-Week Open-Label Long-Term Safety and Tolerability Study of PD 0332334 in subjects with Generalized Anxiety Disorder."      

Research study of an investigational medication for adults 18 and up.

Protocol LUAA21004_309:  "A Phase 3 Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of LU AA21004 in Acute Treatment of adults with Generalized Anxiety Disorder.

Research study of an investigational medication for adults 18 and up.

Bipolar Depression:

Protocol A1281158: "A Six-Week, Double-Blind, Multicenter, Placebo- Controlled Study Evaluating the Efficacy and Safety of Flexible Doses of Oral Ziprasidone as add-on, Adjunctive Therapy with Lithium, Valproate or Lamotrigine in Bipolar I Depression."

Research study of the effectiveness and safety of Ziprasidone in combination with a mood stabilizer (lithium, valproate or lamotrigine) for treatment of Bipolar I depression who are at least 18 years of age.

Child ADHD:

Protocol SPF503-313:  "A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Optimization Study Evaluating the Efficacy and Safety of SPD503 in Combination with Psychostimulants in Children and Adolescents, 6-17 years of age who have been diagnosed with ADHD.

Child Bipolar:

Protocol SCA102833:  "A Phase 3 Multicenter, Parallel Group, Placebo-Controlled, Double-Blind, Randomized Study Evaluating Lamictal as an Add-On Maintenance Treatment in Children and Adolescents, 10-17 years of age who have been diagnosed with Bipolar Disorder.

Depression:

Protocol CAGO178A2304: “A 52-week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 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.” This investigational drug is the first in a new class of antidepressants which targets melatonin for adults 18-70 years of age.

Protocol PKI113009: “A six-week randomized, double-blind, multi-center, placebo-controlled, exploratory, adaptive design study to explore the antidepressant properties of the p38 MAP kinase inhibitor GW856553 compared to placebo in adult subjects with Major Depressive Disorder.” Research study for subjects 18-60 year old, currently depressed who had at least one previous episode of depression.

Protocol iSPOT-D: “International Study to Predict Optimised Treatment – in Depression.” Research study for subjects 18-65 year old, currently depressed and willing to take one of 3 FDA-approved antidepressants.

For more information about any of the clinical trials listed above, please call contact The Ohio State University, Department of Psychiatry at (614) 293-7109 or e-mail clinicaltrials@osumc.edu