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

Purpose

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

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: PD 0332334 Drug: Placebo	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response rate on the clinician-rated CGI-I at Week 1 and Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Response rate on the HAM-A at Week 1 and Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Remission rate based on the HAM-A at Week 1 and Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Response rate on the patient-rated PGI-C at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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). [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Change from Baseline in HAM-A total score at Weeks 1, 2, 4, and 6. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 8 on the Sheehan Disability Scale subscales. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in CGI-S at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 8 in the Q-Les-Q General Activities Score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	551
Study Start Date:	October 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PD 0332334 300 mg BID	Drug: PD 0332334 Capsules, oral, 300 mg BID, 8 weeks with 2 week taper. Other Name: imagabalin
Placebo Comparator: Placebo BID	Drug: Placebo Capsules, oral, placebo BID, 8 weeks with 2 week taper.
Experimental: PD 0332334 225 mg BID	Drug: PD 0332334 Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
Experimental: PD 0332334 175 mg BID	Drug: PD 0332334 Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542685

Show 43 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00542685 History of Changes
Other Study ID Numbers:	A5361017
Study First Received:	October 10, 2007
Last Updated:	November 9, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013