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

Generalized Anxiety Disorder Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group, 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542685
• Other study ID #: A5361017
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2007
• Last updated: November 9, 2012
• Start date: October 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• PD 0332334
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
• Placebo
Capsules, oral, placebo BID, 8 weeks with 2 week taper.
• PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
• PD 0332334
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Belmont	Massachusetts
United States	Pfizer Investigational Site	Beverly Hills	California
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Chapel Hill	North Carolina
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Cherry Hill	New Jersey
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Encino	California
United States	Pfizer Investigational Site	Fall River	Massachusetts
United States	Pfizer Investigational Site	Farmington	Connecticut
United States	Pfizer Investigational Site	Farmington Hills	Michigan
United States	Pfizer Investigational Site	Glen Burnie	Maryland
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Lafayette	Indiana
United States	Pfizer Investigational Site	Lake Charles	Louisiana
United States	Pfizer Investigational Site	Libertyville	Illinois
United States	Pfizer Investigational Site	Lincoln	Rhode Island
United States	Pfizer Investigational Site	Marietta	Georgia
United States	Pfizer Investigational Site	Middleton	Wisconsin
United States	Pfizer Investigational Site	Nashua	New Hampshire
United States	Pfizer Investigational Site	National City	California
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Owensboro	Kentucky
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Piscataway	New Jersey
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Rockville	Maryland
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Schaumburg	Illinois
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Sherman Oaks	California
United States	Pfizer Investigational Site	Staten Island	New York
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study.		8 weeks	Yes
Secondary	Response rate on the clinician-rated CGI-I at Week 1 and Week 8.		8 weeks	No
Secondary	Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales.		8 weeks	No
Secondary	Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score.		8 weeks	No
Secondary	Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score).		8 weeks	No
Secondary	Response rate on the HAM-A at Week 1 and Week 8.		8 weeks	No
Secondary	Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8.		8 weeks	No
Secondary	Remission rate based on the HAM-A at Week 1 and Week 8.		8 weeks	No
Secondary	Response rate on the patient-rated PGI-C at Week 8.		8 weeks	No
Secondary	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	No
Secondary	Change from Baseline in HAM-A total score at Weeks 1, 2, 4, and 6.		6 weeks	No
Secondary	Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8.		8 weeks	No
Secondary	Change from Baseline to Week 8 on the Sheehan Disability Scale subscales.		8 weeks	No
Secondary	Change from Baseline in CGI-S at Week 8.		8 weeks	No
Secondary	Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8.		8 weeks	No
Secondary	Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.		8 weeks	No
Secondary	Change from Baseline to Week 8 in the Q-Les-Q General Activities Score.		8 weeks	No
Secondary	Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.		1 week	No
Secondary	Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary).		8 weeks	No

External Links

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