A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Generalized Anxiety Disorder
Intervention: PD 0332334 (Drug); PD 0332334 (Drug); placebo (Drug); Alprazolam extended release (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to
placebo in the treatment of Generalized Anxiety Disorder in an adult population
Clinical Details
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 5-Week Trial To Assess The Efficacy And Safety Of PD 0332334 Compared To Placebo And Alprazolam Extended-Release In Patients With Generalized Anxiety Disorder
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: HAM-A Total Score
Secondary outcome: HAM-A total score at week 1, 2 and 4HAM-A somatic and psychic subscales HAM-A responders HAM-A sustained responders DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety) CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change) HAM-D total score Sheehan Disability Score (SDS) Treatment Satisfaction Questionaire for Medication
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD)
(Diagnostic and Statistical Manual-IV [DSM-IV], 300. 02).
- HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both
Screening and Baseline/Randomization.
Exclusion Criteria:
- Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive
Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia;
Bulimia; Caffeine-induced anxiety disorder;
- Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder;
Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder;
Dissociative Disorders; Antisocial or borderline personality disorder
- Current use of psychotropic medications (i. e., drugs normally prescribed for
depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2
weeks prior to dosing.
Locations and Contacts
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2005
Last updated: February 17, 2010
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