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

Completed · Phase 3 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder

In brief

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.

Key facts

Study ID

NCT00413010

Run by

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

People needed

356

Starts

2006-12-01

Expected to finish

2008-03-01

Last updated by the study team

2021-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• 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
• Pfizer Investigational Site — Wichita, Kansas, United States
• Pfizer Investigational Site — Shreveport, Louisiana, United States
• Pfizer Investigational Site — Shreveport, Louisiana, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Olive Branch, Mississippi, United States
• Pfizer Investigational Site — Saint Charles, Missouri, United States
• Pfizer Investigational Site — Omaha, Nebraska, United States
• Pfizer Investigational Site — Clementon, New Jersey, United States
• Pfizer Investigational Site — Albuquerque, New Mexico, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Beachwood, Ohio, United States
• Pfizer Investigational Site — Cincinnati, Ohio, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Bala-Cynwyd, Pennsylvania, United States
• Pfizer Investigational Site — Arcadia, California, United States

Full record on ClinicalTrials.gov

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