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A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder | Clinical Trials | Clareo Health

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A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder

A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dosage Study to Evaluate the Efficacy and Safety of Gabitril(up to 16 mg/Day) in the Treatment of Adults With Generalized Anxiety Disorder

NCT00236067•Cephalon

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD).

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S).

Exclusion Criteria

•Have been previously unresponsive to two or more adequate courses of pharmacological treatment for GAD
•Have been diagnosed with any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months
•Have been diagnosed with any eating disorder within the past six months
•Have any history of OCD, psychotic disorder, bipolar disorder or antisocial personality disorder
•Have any history of alcohol or substance abuse within 3 months of screening
•Have any history of seizures, including febrile seizures
•Have any history of head trauma associated with loss of consciousness within the past 15 years

Locations (21)

Birmingham Research Group

Birmingham, Alabama, United States

Southwestern Research Institute

Beverly Hills, California, United States

Pharmacology Research Institute

Northridge, California, United States

Pacific Clinical Research

Orange, California, United States

Carman Research

Smyrna, Georgia, United States

Hawaii Clinical Research Center

Honolulu, Hawaii, United States

Hartford Research Group

Florence, Kentucky, United States

Summit Research Network

Okemos, Michigan, United States

CNS Research Institute

Clementon, New Jersey, United States

Social Psychiatry Research Inst.

Brooklyn, New York, United States

Key Dates

Start Date

October 1, 2004

Completion Date

March 1, 2006

Last Updated

May 9, 2014

Enrollment

440

Estimated participants

Conditions

Generalized Anxiety Disorder

Interventions

Gabitril

DRUG

Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study

NCT07429578

Generalized Anxiety Disorder (GAD)Chronic Insomnia

View study

RECRUITINGNA

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

NCT06661460

ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)Specific Phobia+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder

Inclusion Criteria

Exclusion Criteria

Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

Study to Assess Adverse Events and Change in Disease Activity When Oral ABBV-932 is Added to Antidepressant Therapies in Adult Participants With Generalized Anxiety Disorder

Prospective Clinical Trial of Crisugabalin Capsules in the Treatment of Generalized Anxiety Disorder

Teletherapy vs. In-Person Cognitive Behavioral Therapy for Generalized Anxiety Disorder

Electroclinical Correlation of Anxiety