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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00921063
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : February 19, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Generalized Anxiety Disorder Drug: PD 0332334 Drug: placebo Drug: Alprazolam extended release Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : November 2005
Primary Completion Date : July 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Alprazolam
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. HAM-A Total Score [ Time Frame: 4 weeks ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921063


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00921063     History of Changes
Other Study ID Numbers: A5361007
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: February 19, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Alprazolam
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