A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1)
Phase 3
Terminated
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Registration Number
- NCT00658008
- Lead Sponsor
- Pfizer
- Brief Summary
This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages from 18 to 65, 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
- 501
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 diagnosis: 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 Placebo BID Placebo - PD 0332334 175 mg BID PD 0332334 - PD 0332334 225 mg BID PD 0332334 - Paroxetine 20 mg QD Paroxetine - PD 0332334 75 mg BID PD 0332334 -
- Primary Outcome Measures
Name Time Method The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment. 8 weeks The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study 8 weeks
- Secondary Outcome Measures
Name Time Method Remission rate based on the HAM A at Week 8 8 weeks Change from baseline in CGI-S at week 8 8 weeks Change from baseline to week 8 in the QLesQ General Activity Score 8 weeks Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ) 8 weeks Response rate on the patient-rated PGI-C at week 8 8 weeks Change from baseline to week 8 on the Sheehan Disability Scale subscales 8 weeks Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13) 8 weeks Response rate on the HAM-A at week 1 and week 8 8 weeks Response rate on the clinician-rated CGI-I ate week 1 and week 8 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 Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II 1 week Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II 8 weeks Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6 6 weeks Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8 8 weeks Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales 8 weeks The "Week 1 Sustained Responder" rate based on the HAM A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM A total score at Week 1 that is sustained until the Week 8 visit) 1 week 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 on the Sheehan Disability Scale (SDS) total score 8 weeks Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary) 8 weeks Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score 8 weeks
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇷🇺Khotkovo, Moscow region, Russian Federation