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

NCT00921063

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Generalized Anxiety Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE
  • Drug: PD 0332334
    250 mg capsule, BID for 4 weeks
    Other Name: imagabalin
  • Drug: PD 0332334
    100 mg capsule, BID for 4 weeks
  • Drug: placebo
    0 mg capsule, BID for 4 weeks
  • Drug: Alprazolam extended release
    1 mg capsule, BID for 4 weeks
    Other Name: Xanax XR
Study Arms  ICMJE
  • Experimental: PD 0332334 250 mg
    Intervention: Drug: PD 0332334
  • Experimental: PD 0332334 100 mg
    Intervention: Drug: PD 0332334
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: Alprazolam extended release
    Intervention: Drug: Alprazolam extended release
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2010)
222
Original Actual Enrollment  ICMJE
 (submitted: June 15, 2009)
211
Actual Study Completion Date  ICMJE July 2006
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00921063
Other Study ID Numbers  ICMJE A5361007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP