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

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 Drug: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	An 8-Week, Double-Blind, Placebo-Controlled, Phase 3 Trial of Pregabalin (150-600 mg/Day) in the Adjunctive Treatment of Patients With Generalized Anxiety Disorder (GAD) Who Have Not Optimally Responded to Existing Therapies(GAD)

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in HAM-A Total Score at Weekly Visits [ Time Frame: Baseline, Weeks 1 through Week 8 ] [ Designated as safety issue: No ]
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Weeks 1 through Week 8 ] [ Designated as safety issue: No ]
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score [ Time Frame: Week 1 through Week 8 ] [ Designated as safety issue: No ]
Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score [ Time Frame: Week 1 through Week 8 ] [ Designated as safety issue: No ]
Clinical Global Impression of Severity (CGI-S) Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Change in Hamilton Depression Rating Scale (HAM-D) Total Score [ Time Frame: Weeks 1 through Week 8 ] [ Designated as safety issue: No ]

Enrollment:	356
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
Placebo Comparator: Arm 2	Drug: placebo placebo + concurrent GAD treatment from the open-label study period
Experimental: Arm 1	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 Other Name: Lyrica

Detailed Description:

Further enrollment in this study was stopped on January 28, 2008 based on the recommendation of an independent data monitoring committee. The recommendation to stop the study was not based on 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 (Diagnostic and Statistical Manual of Mental Disorders 4th edition) diagnosis of major depressive disorder with or without seasonal pattern, dysthmic disorder, depressive disorder NOS (not otherwise specified), 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 (Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision).
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

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rickels K, Shiovitz TM, Ramey TS, Weaver JJ, Knapp LE, Miceli JJ. Adjunctive therapy with pregabalin in generalized anxiety disorder patients with partial response to SSRI or SNRI treatment. Int Clin Psychopharmacol. 2012 May;27(3):142-50.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00413010 History of Changes
Other Study ID Numbers:	A0081103
Study First Received:	December 15, 2006
Results First Received:	February 27, 2009
Last Updated:	December 3, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 21, 2013