A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder
Phase 2
Completed
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Registration Number
- NCT00921063
- Lead Sponsor
- Pfizer
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PD 0332334 250 mg PD 0332334 - PD 0332334 100 mg PD 0332334 - placebo placebo - Alprazolam extended release Alprazolam extended release -
- Primary Outcome Measures
Name Time Method HAM-A Total Score 4 weeks
- Secondary Outcome Measures
Name Time Method HAM-A total score at week 1, 2 and 4 1. 2. ands 4 weeks HAM-A somatic and psychic subscales 1, 2, and 4 weeks HAM-A responders 4 weeks HAM-A sustained responders Week 1 through week 4 DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety) Day 2 through day 7 CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change) 1 and 4 weeks HAM-D total score 1 and 4 weeks Sheehan Disability Score (SDS) 4 weeks Treatment Satisfaction Questionaire for Medication 4 weeks