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

This study has been completed.

Sponsor:

Information provided by:

Cephalon

ClinicalTrials.gov Identifier:

NCT00236054

First received: October 7, 2005

Last updated: April 12, 2006

Last verified: April 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	October 7, 2005
Last Updated Date	April 12, 2006
Start Date ^ICMJE	October 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: October 14, 2005)	Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to endpoint in the total score of the HAM-A scale.
Original Primary Outcome Measures ^ICMJE (submitted: October 7, 2005)	Reduction of symptomatology associated with Generalized Anxiety Disorder
Change History	Complete list of historical versions of study NCT00236054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 14, 2005)	Assessment of proportion of responders and patients in remission according to HAM-A scores and CGI ratings by visit, assessment of the safety and tolerability in patients with GAD
Original Secondary Outcome Measures ^ICMJE (submitted: October 7, 2005)	Reduction of symptomatology as assessed by the change from baseline in the total score of the HAM-A scale
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
Official Title ^ICMJE	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
Brief 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)
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Generalized Anxiety Disorder
Intervention ^ICMJE	Drug: Gabitril
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	440
Completion Date	December 2005
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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 the past 3 months Have any history of seizures, including febrile seizures Have any history of head trauma associated with loss of consciousness within the past 15 years
Gender	Both
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00236054
Other Study ID Numbers ^ICMJE	C6671/3032/AX/US
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Cephalon
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Cephalon
Verification Date	April 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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