A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00921063
First received: June 15, 2009
Last updated: February 17, 2010
Last verified: February 2010
  Purpose

The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population


Condition Intervention Phase
Generalized Anxiety Disorder
Drug: PD 0332334
Drug: placebo
Drug: Alprazolam extended release
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 5-Week Trial To Assess The Efficacy And Safety Of PD 0332334 Compared To Placebo And Alprazolam Extended-Release In Patients With Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • HAM-A Total Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HAM-A total score at week 1, 2 and 4 [ Time Frame: 1. 2. ands 4 weeks ] [ Designated as safety issue: No ]
  • HAM-A somatic and psychic subscales [ Time Frame: 1, 2, and 4 weeks ] [ Designated as safety issue: No ]
  • HAM-A responders [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • HAM-A sustained responders [ Time Frame: Week 1 through week 4 ] [ Designated as safety issue: No ]
  • DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety) [ Time Frame: Day 2 through day 7 ] [ Designated as safety issue: No ]
  • CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change) [ Time Frame: 1 and 4 weeks ] [ Designated as safety issue: No ]
  • HAM-D total score [ Time Frame: 1 and 4 weeks ] [ Designated as safety issue: No ]
  • Sheehan Disability Score (SDS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Treatment Satisfaction Questionaire for Medication [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 222
Study Start Date: November 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PD 0332334 250 mg Drug: PD 0332334
250 mg capsule, BID for 4 weeks
Other Name: imagabalin
Experimental: PD 0332334 100 mg Drug: PD 0332334
100 mg capsule, BID for 4 weeks
Placebo Comparator: placebo Drug: placebo
0 mg capsule, BID for 4 weeks
Active Comparator: Alprazolam extended release Drug: Alprazolam extended release
1 mg capsule, BID for 4 weeks
Other Name: Xanax XR

  Eligibility

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

Inclusion Criteria:

  • Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD) (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02).
  • HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both Screening and Baseline/Randomization.

Exclusion Criteria:

  • Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder;
  • Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder; Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder; Dissociative Disorders; Antisocial or borderline personality disorder
  • Current use of psychotropic medications (i.e., drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921063

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00921063     History of Changes
Other Study ID Numbers: A5361007
Study First Received: June 15, 2009
Last Updated: February 17, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014