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: Drug: paroxetine; Drug: Placebo; Drug: PD 0332334

• 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.

Study Timeline

• Study First Submitted: 2008-04-09
• Study First Submitted QC: 2008-04-09
• Study First Posted: 2008-04-15
• Study Start: 2008-05
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Disposition First Submitted: 2010-08-25
• Disposition First Submitted QC: 2010-08-25
• Disposition First Posted: 2010-08-30
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-09
• Last Update Posted: 2012-11-16

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; 🇭🇺 Budapest, Hungary