CLINICAL TRIALS PROFILE FOR GABITRIL

All Clinical Trials for GABITRIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00174850 ↗	Switching From an SSRI to Tiagabine(GABITRIL) in Order to Alleviate SSRI Induced Sexual Dysfunction	Completed	State University of New York - Upstate Medical University	Phase 4	2004-07-01	Anxious patients are now treated with Selective Serotonin Reuptake Inhibitor medications (common antidepressants) which elevate serotonin and thus alleviate anxiety. These medications have clearly proven efficacy upwards of 70% for many anxiety disorders. In regards to tolerability, they have a major problem in that they often produce sexual dysfunction in men and women (ie. decreased libido, anorgasmia, impotence) upwards of 30% of the time. Benzodiazepine anxiolytics are also FDA approved to treat anxiety with equal efficacy and greater tolerability (very little, if any sexual dysfunction). They do, however, carry a substantial risk for addiction. Tiagabine is a Selective GABA Reuptake Inhibitor (SGRI) that is FDA approved to treat certain types of epilepsy. Like benzodiazepines, Tiagabine also increases the neurotransmitter, GABA, in the brain and is thought to alleviate anxiety (see references below) this way too, but without any addiction risk common to Valium-type drugs. The safety profile of Tiagabine is thought to be much safer. Two double blind studies are ongoing which are looking at Tiagabine's effectiveness in PTSD and GAD. There are many open label studies showing anxiety reduction and many psychiatrists in clinical practice are utilizing this agent as an anxiety treatment in an off-label manner. This study is designed to evaluate anxious patients who are taking SSRI medication, have had a reasonable response, but are experiencing significant sexual side effects which are pushing them towards noncompliance and possible relapse into anxiety. 30 subjects (15 men and 15 women) will be asked to join the study and be placed on Tiagabine as well as their current SSRI. Once an acceptable dose of Tiagabine is reached in the first four weeks, the subjects' SSRIs will be slowly stopped. Two weeks after enrollment, all subjects will be called in order to check for any side effects to the study drug and to insure that each subject is titrating to the proper dose of study drug according to the study protocol. An open-label, non-placebo prospective 10 week follow up will occur, where the now Tiagabine monotherapy subjects will be followed to see primarily if their sexual dysfunction improves and if there anxiety remains controlled.
NCT00179465 ↗	Treating Schizophrenia by Correcting Abnormal Brain Development	Active, not recruiting	Dartmouth-Hitchcock Medical Center	Phase 3	2003-11-01	The purpose of this study is to determine whether treatment with tiagabine (Gabitril) during the early course of schizophrenia can fundamentally correct the brain deficits associated with the disease. This study is funded by the National Institutes of Health.
NCT00179465 ↗	Treating Schizophrenia by Correcting Abnormal Brain Development	Active, not recruiting	Beth Israel Deaconess Medical Center	Phase 3	2003-11-01	The purpose of this study is to determine whether treatment with tiagabine (Gabitril) during the early course of schizophrenia can fundamentally correct the brain deficits associated with the disease. This study is funded by the National Institutes of Health.
NCT00208741 ↗	Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder	Completed	Cephalon	Phase 4	2002-06-01	The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).
NCT00208741 ↗	Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder	Completed	Emory University	Phase 4	2002-06-01	The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).

Clinical Trial Conditions for GABITRIL

Condition Name

Condition Name for GABITRIL
Intervention	Trials
Generalized Anxiety Disorder	2
Social Anxiety Disorder	1
Alcoholism	1
Anxiety	1

Condition MeSH

Condition MeSH for GABITRIL
Intervention	Trials
Anxiety Disorders	7
Disease	6
Phobia, Social	1
Sleep Apnea, Obstructive	1

Clinical Trial Locations for GABITRIL

Trials by Country

Trials by Country for GABITRIL
Location	Trials
United States	113
Canada	10

Trials by US State

Trials by US State for GABITRIL
Location	Trials
New York	7
Georgia	6
California	5
Massachusetts	5
Pennsylvania	5

Clinical Trial Progress for GABITRIL

Clinical Trial Phase

Clinical Trial Phase for GABITRIL
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	6
Phase 2	1

Clinical Trial Status

Clinical Trial Status for GABITRIL
Clinical Trial Phase	Trials
Completed	9
Active, not recruiting	1

Clinical Trial Sponsors for GABITRIL

Sponsor Name

Sponsor Name for GABITRIL
Sponsor	Trials
Cephalon	6
Rajesh Narendran	1
Brigham and Women's Hospital	1

Sponsor Type

Sponsor Type for GABITRIL
Sponsor	Trials
Other	6
Industry	6