search
Back to results

A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)

Primary Purpose

Generalized Anxiety Disorder

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PD 0332334
PD 0332334
paroxetine
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of GAD (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic disorder will be allowed in the study.
  • Subjects must have a HAM-A total score >/= 20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of >/= 9 and a Raskin Depression Scale score </= 7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.

Exclusion Criteria:

  • Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
  • Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses: Major depressive disorder; Obsessive compulsive disorder; Panic disorder; Agoraphobia; Posttraumatic stress disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder; Alcohol or substance abuse or dependence unless in full remission for at least 6 months; Social anxiety disorder.
  • Any of the following past or current DSM-IV Axis I diagnoses: Schizophrenia; Psychotic disorder; Delirium, dementia, amnestic and other clinically significant cognitive disorders; Bipolar or schizoaffective disorder; Cyclothymic disorder; Dissociative disorders.
  • Antisocial or borderline personality disorder.
  • Serious suicidal risk per the clinical investigator's judgment.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

PD 0332334 225 mg BID

PD 0332334 300 mg BID

Paroxetine 20 mg q am

Placebo BID

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in HAM-A total score at Week 8
To assess the safety and tolerability of PD 0332334 in subjects with GAD

Secondary Outcome Measures

Response rate on the HAM-A at Week 1 and Week 8
Remission rate based on the HAM-A at Week 8
Change from Baseline in the somatic subscale score of the HAM-A (item 7-13) at Week 8
Change from Baseline to Week 8 on the Medical Outcomes Study - Sleep Scale subscales
Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ).
Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score
Change from Baseline in the HAM-A total score at Weeks 1, 2, 4 and 6)
Response rate on the PGI-C at Week 8
Response rate on the CGI-I at Week 1 and Week 8
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score
Average (across the Week 1, 2, 4, 6 and 8 visits) HAM-A Change from Baseline score
Change from Baseline to Days 2-8 and Weeks 2, 4, 6 and 8 on the GA-VAS (diary)
The "Week 1 Sustained Responser" rate based on the HAM-A
Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8.
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score)
Change from Baseline to Week 8 in the Q-Les-Q General Activities Score
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score
Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8
Change from Baseline in CGI-S at Week 8

Full Information

First Posted
April 9, 2008
Last Updated
November 9, 2012
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00658762
Brief Title
A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)
Official Title
A Phase 3, Randomized, Double-Blind, Parallel Group, 10-Week Placebo Controlled Fixed Dose Study of PD 0332334 and Paroxetine Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
Please see Detailed Description for termination reason.
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects ages 18 and older with generalized anxiety disorder.
Detailed Description
Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD 0332334 225 mg BID
Arm Type
Experimental
Arm Title
PD 0332334 300 mg BID
Arm Type
Experimental
Arm Title
Paroxetine 20 mg q am
Arm Type
Active Comparator
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PD 0332334
Other Intervention Name(s)
imagabalin
Intervention Description
Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper
Intervention Type
Drug
Intervention Name(s)
PD 0332334
Intervention Description
Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper
Intervention Type
Drug
Intervention Name(s)
paroxetine
Intervention Description
Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules, oral, BID, 8 weeks, with 2 week taper
Primary Outcome Measure Information:
Title
Change from Baseline in HAM-A total score at Week 8
Time Frame
8 weeks
Title
To assess the safety and tolerability of PD 0332334 in subjects with GAD
Time Frame
8 weeks with taper
Secondary Outcome Measure Information:
Title
Response rate on the HAM-A at Week 1 and Week 8
Time Frame
8 weeks
Title
Remission rate based on the HAM-A at Week 8
Time Frame
8 weeks
Title
Change from Baseline in the somatic subscale score of the HAM-A (item 7-13) at Week 8
Time Frame
8 weeks
Title
Change from Baseline to Week 8 on the Medical Outcomes Study - Sleep Scale subscales
Time Frame
8 weeks
Title
Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ).
Time Frame
8 weeks
Title
Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score
Time Frame
8 weeks
Title
Change from Baseline in the HAM-A total score at Weeks 1, 2, 4 and 6)
Time Frame
6 weeks
Title
Response rate on the PGI-C at Week 8
Time Frame
8 weeks
Title
Response rate on the CGI-I at Week 1 and Week 8
Time Frame
8 weeks
Title
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score
Time Frame
8 weeks
Title
Average (across the Week 1, 2, 4, 6 and 8 visits) HAM-A Change from Baseline score
Time Frame
8 weeks
Title
Change from Baseline to Days 2-8 and Weeks 2, 4, 6 and 8 on the GA-VAS (diary)
Time Frame
8 weeks
Title
The "Week 1 Sustained Responser" rate based on the HAM-A
Time Frame
8 weeks
Title
Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8.
Time Frame
8 weeks
Title
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score)
Time Frame
8 weeks
Title
Change from Baseline to Week 8 in the Q-Les-Q General Activities Score
Time Frame
8 weeks
Title
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score
Time Frame
1 week
Title
Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8
Time Frame
8 weeks
Title
Change from Baseline in CGI-S at Week 8
Time Frame
8 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: Diagnosis of GAD (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic disorder will be allowed in the study. Subjects must have a HAM-A total score >/= 20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of >/= 9 and a Raskin Depression Scale score </= 7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms. Exclusion Criteria: Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies). Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses: Major depressive disorder; Obsessive compulsive disorder; Panic disorder; Agoraphobia; Posttraumatic stress disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder; Alcohol or substance abuse or dependence unless in full remission for at least 6 months; Social anxiety disorder. Any of the following past or current DSM-IV Axis I diagnoses: Schizophrenia; Psychotic disorder; Delirium, dementia, amnestic and other clinically significant cognitive disorders; Bipolar or schizoaffective disorder; Cyclothymic disorder; Dissociative disorders. Antisocial or borderline personality disorder. Serious suicidal risk per the clinical investigator's judgment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35226
Country
United States
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Pfizer Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pfizer Investigational Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Pfizer Investigational Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Pfizer Investigational Site
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
Country
United States
Facility Name
Pfizer Investigational Site
City
Ft. Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Pfizer Investigational Site
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Pfizer Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Pfizer Investigational Site
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
Pfizer Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021-4256
Country
United States
Facility Name
Pfizer Investigational Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Pfizer Investigational Site
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-1998
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Pfizer Investigational Site
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Pfizer Investigational Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Pfizer Investigational Site
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Pfizer Investigational Site
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1135
Country
Hungary

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5361020&StudyName=A%2010-week%20Study%20Evaluating%20the%20Efficacy%20and%20Safety%20of%20PD%200332334%20for%20the%20Treatment%20of%20Generalized%20Anxiety%20Disorder%20%283%29
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)

We'll reach out to this number within 24 hrs