A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder
Primary Purpose
Generalized Anxiety Disorder
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PD 0332334
PD 0332334
placebo
Alprazolam extended release
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
PD 0332334 250 mg
PD 0332334 100 mg
placebo
Alprazolam extended release
Arm Description
Outcomes
Primary Outcome Measures
HAM-A Total Score
Secondary Outcome Measures
HAM-A total score at week 1, 2 and 4
HAM-A somatic and psychic subscales
HAM-A responders
HAM-A sustained responders
DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety)
CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change)
HAM-D total score
Sheehan Disability Score (SDS)
Treatment Satisfaction Questionaire for Medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00921063
Brief Title
A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder
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 Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PD 0332334 250 mg
Arm Type
Experimental
Arm Title
PD 0332334 100 mg
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
Alprazolam extended release
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PD 0332334
Other Intervention Name(s)
imagabalin
Intervention Description
250 mg capsule, BID for 4 weeks
Intervention Type
Drug
Intervention Name(s)
PD 0332334
Intervention Description
100 mg capsule, BID for 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
0 mg capsule, BID for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Alprazolam extended release
Other Intervention Name(s)
Xanax XR
Intervention Description
1 mg capsule, BID for 4 weeks
Primary Outcome Measure Information:
Title
HAM-A Total Score
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
HAM-A total score at week 1, 2 and 4
Time Frame
1. 2. ands 4 weeks
Title
HAM-A somatic and psychic subscales
Time Frame
1, 2, and 4 weeks
Title
HAM-A responders
Time Frame
4 weeks
Title
HAM-A sustained responders
Time Frame
Week 1 through week 4
Title
DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety)
Time Frame
Day 2 through day 7
Title
CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change)
Time Frame
1 and 4 weeks
Title
HAM-D total score
Time Frame
1 and 4 weeks
Title
Sheehan Disability Score (SDS)
Time Frame
4 weeks
Title
Treatment Satisfaction Questionaire for Medication
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5361007&StudyName=A%205-Week%20Trial%20Of%20PD%200332334%20And%20Alprazolam%20Extended%20Release%20Compared%20To%20Placebo%20In%20Patients%20With%20Generalized%20Anxiety%20Disorder
Description
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A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder
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