A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)
Phase 3
Terminated
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Registration Number
- NCT00658762
- Lead Sponsor
- Pfizer
- Brief Summary
This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects ages 18 and older with generalized anxiety disorder.
- Detailed Description
Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 286
Inclusion Criteria
- Diagnosis of GAD (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic disorder will be allowed in the study.
- Subjects must have a HAM-A total score >/= 20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of >/= 9 and a Raskin Depression Scale score </= 7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.
Exclusion Criteria
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
- Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses: Major depressive disorder; Obsessive compulsive disorder; Panic disorder; Agoraphobia; Posttraumatic stress disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder; Alcohol or substance abuse or dependence unless in full remission for at least 6 months; Social anxiety disorder.
- Any of the following past or current DSM-IV Axis I diagnoses: Schizophrenia; Psychotic disorder; Delirium, dementia, amnestic and other clinically significant cognitive disorders; Bipolar or schizoaffective disorder; Cyclothymic disorder; Dissociative disorders.
- Antisocial or borderline personality disorder.
- Serious suicidal risk per the clinical investigator's judgment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paroxetine 20 mg q am paroxetine - Placebo BID Placebo - PD 0332334 225 mg BID PD 0332334 - PD 0332334 300 mg BID PD 0332334 -
- Primary Outcome Measures
Name Time Method Change from Baseline in HAM-A total score at Week 8 8 weeks To assess the safety and tolerability of PD 0332334 in subjects with GAD 8 weeks with taper
- Secondary Outcome Measures
Name Time Method Response rate on the CGI-I at Week 1 and Week 8 8 weeks Response rate on the PGI-C at Week 8 8 weeks Response rate on the HAM-A at Week 1 and Week 8 8 weeks Remission rate based on the HAM-A at Week 8 8 weeks Change from Baseline in the somatic subscale score of the HAM-A (item 7-13) at Week 8 8 weeks Change from Baseline to Week 8 on the Medical Outcomes Study - Sleep Scale subscales 8 weeks Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ). 8 weeks Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score 8 weeks Change from Baseline in the HAM-A total score at Weeks 1, 2, 4 and 6) 6 weeks Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score 8 weeks Average (across the Week 1, 2, 4, 6 and 8 visits) HAM-A Change from Baseline score 8 weeks Change from Baseline to Days 2-8 and Weeks 2, 4, 6 and 8 on the GA-VAS (diary) 8 weeks The "Week 1 Sustained Responser" rate based on the HAM-A 8 weeks Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8. 8 weeks Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score) 8 weeks Change from Baseline to Week 8 in the Q-Les-Q General Activities Score 8 weeks Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score 1 week Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8 8 weeks Change from Baseline in CGI-S at Week 8 8 weeks
Trial Locations
- Locations (1)
Pfizer Investigational Site
ðŸ‡ðŸ‡ºBudapest, Hungary