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Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD). | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).

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)

NCT00413010•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

Summary

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.

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).

Locations (68)

Pfizer Investigational Site

Arcadia, California, United States

Pfizer Investigational Site

Burbank, California, United States

Pfizer Investigational Site

Redlands, California, United States

Pfizer Investigational Site

Sherman Oaks, California, United States

Pfizer Investigational Site

Norwich, Connecticut, United States

Pfizer Investigational Site

Destin, Florida, United States

Pfizer Investigational Site

Fort Walton Beach, Florida, United States

Pfizer Investigational Site

Miami, Florida, United States

Pfizer Investigational Site

South Miami, Florida, United States

Pfizer Investigational Site

Overland Park, Kansas, United States

Key Dates

Start Date

December 1, 2006

Primary Completion Date

February 1, 2008

Completion Date

March 1, 2008

Last Updated

February 10, 2021

Enrollment

356

ACTUAL participants

Conditions

Generalized Anxiety Disorder

Interventions

pregabalin

DRUG

placebo

DRUG

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

NCT07429578

Generalized Anxiety Disorder (GAD)Chronic Insomnia

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RECRUITINGNA

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

NCT06661460

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

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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: February 10, 2021Data 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.

View ClinicalTrials.gov Terms and Conditions

Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).

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