A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

Phase 3

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Drug: PD 0332334; Drug: Placebo

• Registration Number: NCT00542685
• Lead Sponsor: Pfizer

Brief Summary

This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-10
• Study First Posted: 2007-10-11
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Disposition First Submitted: 2009-12-10
• Disposition First Submitted QC: 2009-12-10
• Disposition First Posted: 2009-12-14
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-09
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 551

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD 0332334 175 mg BID	PD 0332334	-
PD 0332334 300 mg BID	PD 0332334	-
Placebo BID	Placebo	-
PD 0332334 225 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
Response rate on the clinician-rated CGI-I at Week 1 and Week 8.	8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales.	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, 8 on the DAS-A (total score).	8 weeks
Response rate on the HAM-A at Week 1 and Week 8.	8 weeks
Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8.	8 weeks
Remission rate based on the HAM-A at Week 1 and Week 8.	8 weeks
Response rate on the patient-rated PGI-C at Week 8.	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 in 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 Sheehan Disability Scale subscales.	8 weeks
Change from Baseline in CGI-S at 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 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) 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) total score.	1 week
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary).	8 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Middleton, Wisconsin, United States