A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00542685
First received: October 10, 2007
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.


Condition Intervention Phase
Generalized Anxiety Disorder
Drug: PD 0332334
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group, 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate on the clinician-rated CGI-I at Week 1 and Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Response rate on the HAM-A at Week 1 and Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Remission rate based on the HAM-A at Week 1 and Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Response rate on the patient-rated PGI-C at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The "Week 1 Sustained Responder" rate based on the HAM-A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM-A total score at Week 1 that is sustained until the Week 8 visit). [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Change from Baseline in HAM-A total score at Weeks 1, 2, 4, and 6. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 8 on the Sheehan Disability Scale subscales. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in CGI-S at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 8 in the Q-Les-Q General Activities Score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 551
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PD 0332334 300 mg BID Drug: PD 0332334
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
Other Name: imagabalin
Placebo Comparator: Placebo BID Drug: Placebo
Capsules, oral, placebo BID, 8 weeks with 2 week taper.
Experimental: PD 0332334 225 mg BID Drug: PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
Experimental: PD 0332334 175 mg BID Drug: PD 0332334
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542685

  Show 43 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00542685     History of Changes
Other Study ID Numbers: A5361017
Study First Received: October 10, 2007
Last Updated: November 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014