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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.
Information provided by:
Pfizer Identifier:
First received: June 15, 2009
Last updated: February 17, 2010
Last verified: February 2010
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

Secondary Outcome Measures:
  • HAM-A total score at week 1, 2 and 4 [ Time Frame: 1. 2. ands 4 weeks ]
  • HAM-A somatic and psychic subscales [ Time Frame: 1, 2, and 4 weeks ]
  • HAM-A responders [ Time Frame: 4 weeks ]
  • HAM-A sustained responders [ Time Frame: Week 1 through week 4 ]
  • DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety) [ Time Frame: Day 2 through day 7 ]
  • CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change) [ Time Frame: 1 and 4 weeks ]
  • HAM-D total score [ Time Frame: 1 and 4 weeks ]
  • Sheehan Disability Score (SDS) [ Time Frame: 4 weeks ]
  • Treatment Satisfaction Questionaire for Medication [ Time Frame: 4 weeks ]

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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00921063

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00921063     History of Changes
Other Study ID Numbers: A5361007
Study First Received: June 15, 2009
Last Updated: February 17, 2010

Additional relevant MeSH terms:
Anxiety Disorders
Pathologic Processes
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 16, 2017