Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD). - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00413010

Purpose

The primary objective of this study is to evaluate the efficacy of pregabalin as compared to placebo in the treatment of patients with general anxiety disorder (GAD). Efficacy will be measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM-A) scores from baseline observed following 8 weeks of double-blind treatment or at earlier termination during the double-blind treatment phase and analyzed using a mixed linear model for repeated measures.

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: pregabalin Other: placebo	Phase III

MedlinePlus related topics: Anxiety

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	An 8-Week Double-Blind, Placebo-Controlled, Phase 3 Trial of Pregabalin (150 - 600 mg/Day) in the Treatment of Patients With Generalized Anxiety Disorder (GAD)

Further study details as provided by Pfizer:

Primary Outcome Measures:

Improvement in the total Hamilton Anxiety Rating Scale (HAM-A) scores from baseline to 8 week of double-blind treatment or at earlier termination during the DB treatment phase analyzed using a mixed linear model for repeated measures. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HAM-A responders (greater than/equal to 50% decrease in total HAM-A scores from baseline through Week 8) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Time to onset of sustained HAM-A improvement (greater than/equal to 50% reduction in HAM-A score from baseline) [ Time Frame: during 8 weeks ] [ Designated as safety issue: No ]
HAM-A Psychic Anxiety and Somatic subscale changes [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Remission rate (HAM-A less than/equal to 7) in subjects at last study week [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
Hamilton Depression Rating Scale score change from baseline through week 8 [ Time Frame: through week 8 ] [ Designated as safety issue: No ]
Sheehan Disability Scale (SDS) total and domain scale change from baseline [ Time Frame: through week 8 ] [ Designated as safety issue: No ]
CGI-S at the subject's last study week [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
Changes in the Daily Diary and Daily Assessment of Symptoms-Anxiety (DAS-A) and Global Anxiety-Visual Analogue Scale (GA-VAS) component and total scores from baseline [ Time Frame: through week 1 ] [ Designated as safety issue: No ]
CGI-I responders (CGI-I greater than/equal to 2, much improved or very much improved) at the subject's last study week. [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
HAM-A changes from baseline by week [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	399
Study Start Date:	December 2006
Study Completion Date:	March 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 2: Placebo Comparator	Other: placebo placebo + concurrent GAD treatment from the open-label study period
Arm 1: Experimental	Drug: pregabalin pregabalin 150-600 mg/day flexibly dosed for the first 6 weeks and fixed dosed for the last 2 weeks of total 8 weeks of double blind study period, + concurrent GAD treatment from the open-label study period

Detailed Description:

Further enrollment in this study was stopped on January 28, 2008 based on the recommendation of an independent data monitoring committee. Based on an interim analysis involving 40% enrollment, the data did not suggest the potential for robust efficacy. The study was not stopped for any safety findings.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult male and female subjects with primary DSM-IV diagnosis of GAD, as confirmed by the MINI structured interview.
Historical failure to respond optimally to a GAD treatment

Exclusion Criteria:

Current primary DSM-IV diagnosis of major depressive disorder with or without seasonal pattern, dysthmic disorder, depressive disorder NOS, social phobia, panic disorder with or without agoraphobia, post traumatic stress disorder, dissociative disorder, borderline personality disorder, obsessive-compulsive disorder, antisocial personality disorder, as defined in the DSM-IV TR.
Past and/or current DSM-IV diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive disorder (including delirium, dementia, and amnestic disorder).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413010

Show 68 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0081103
Study First Received:	December 15, 2006
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00413010 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Pregabalin

Peripheral Nervous System Agents
Analgesics
Anticonvulsants

Additional relevant MeSH terms:

Disease
Physiological Effects of Drugs
Pregabalin
Pharmacologic Actions
Pathologic Processes
Anxiety Disorders
Mental Disorders

Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009