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

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

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.

Study Overview

• Status: Terminated
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Drug: PD 0332334; Drug: PD 0332334; Drug: paroxetine; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 286
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1135
    • Pfizer Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35226
      • Pfizer Investigational Site
  • California
    • Glendale, California, United States, 91206
      • Pfizer Investigational Site
    • Orange, California, United States, 92868
      • Pfizer Investigational Site
    • Temecula, California, United States, 92591
      • Pfizer Investigational Site
    • Upland, California, United States, 91786
      • Pfizer Investigational Site
    • Wildomar, California, United States, 92595
      • Pfizer Investigational Site
  • Florida
    • Ft. Myers, Florida, United States, 33912
      • Pfizer Investigational Site
    • Orange City, Florida, United States, 32763
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Pfizer Investigational Site
    • Marietta, Georgia, United States, 30060
      • Pfizer Investigational Site
  • Indiana
    • Greenwood, Indiana, United States, 46143
      • Pfizer Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Pfizer Investigational Site
  • New York
    • New York, New York, United States, 10021-4256
      • Pfizer Investigational Site
    • Syracuse, New York, United States, 13210
      • Pfizer Investigational Site
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45227
      • Pfizer Investigational Site
    • Cleveland, Ohio, United States, 44109-1998
      • Pfizer Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Pfizer Investigational Site
    • Oklahoma City, Oklahoma, United States, 73116
      • Pfizer Investigational Site
  • Oregon
    • Salem, Oregon, United States, 97301
      • Pfizer Investigational Site
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Pfizer Investigational Site
    • Norristown, Pennsylvania, United States, 19401
      • Pfizer Investigational Site
  • Texas
    • Dallas, Texas, United States, 75231
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77008
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77074
      • Pfizer Investigational Site
  • Vermont
    • Woodstock, Vermont, United States, 05091
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD 0332334 225 mg BID	Drug: PD 0332334; Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper; Other Names: imagabalin; Drug: PD 0332334; Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper
Placebo Comparator: Placebo BID	Drug: Placebo; Capsules, oral, BID, 8 weeks, with 2 week taper
Experimental: PD 0332334 300 mg BID	Drug: PD 0332334; Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper; Other Names: imagabalin; Drug: PD 0332334; Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper
Active Comparator: Paroxetine 20 mg q am	Drug: paroxetine; Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: April 9, 2008
• First Submitted That Met QC Criteria: April 9, 2008
• First Posted (Estimate): April 15, 2008

Study Record Updates

• Last Update Posted (Estimate): November 16, 2012
• Last Update Submitted That Met QC Criteria: November 9, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: A5361020