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

NCT00542685 | Completed Phase 3 DMC

• 1 other identifier: A5361017
• Study Type: interventional
• Target: 551
• Locations: 1 country
• Sites: 43

Brief Summary

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

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  8 weeks

• The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study.

  8 weeks

Secondary Outcomes (18)

• Response rate on the clinician-rated CGI-I at Week 1 and Week 8.

  8 weeks

• Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales.

  8 weeks

• Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score.

  8 weeks

• Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score).

  8 weeks

• Response rate on the HAM-A at Week 1 and Week 8.

  8 weeks

Study Arms (4)

PD 0332334 300 mg BID

EXPERIMENTAL

Drug: PD 0332334

Placebo BID

PLACEBO COMPARATOR

Drug: Placebo

PD 0332334 225 mg BID

EXPERIMENTAL

Drug: PD 0332334

PD 0332334 175 mg BID

EXPERIMENTAL

Drug: PD 0332334

Interventions

PD 0332334 DRUG

Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.

Also known as: imagabalin

PD 0332334 300 mg BID

Placebo DRUG

Capsules, oral, placebo BID, 8 weeks with 2 week taper.

Placebo BID

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (43)

Pfizer Investigational Site

Beverly Hills, California, 90210, United States

Location

Pfizer Investigational Site

Encino, California, 91316, United States

Location

Pfizer Investigational Site

National City, California, 91950, United States

Location

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Newport Beach, California, 92660-2452, United States

Location

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San Diego, California, 92103, United States

Location

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Sherman Oaks, California, 91403, United States

Location

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Farmington, Connecticut, 06030-6415, United States

Location

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Jacksonville, Florida, 32216, United States

Location

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Jacksonville, Florida, 32256-2006, United States

Location

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Orlando, Florida, 32806, United States

Location

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Tampa, Florida, 33613, United States

Location

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West Palm Beach, Florida, 33407, United States

Location

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Atlanta, Georgia, 30308, United States

Location

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Atlanta, Georgia, 30328, United States

Location

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Marietta, Georgia, 30060, United States

Location

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Libertyville, Illinois, 60048, United States

Location

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Schaumburg, Illinois, 60194, United States

Location

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Lafayette, Indiana, 47905, United States

Location

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Owensboro, Kentucky, 42301, United States

Location

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Lake Charles, Louisiana, 70601, United States

Location

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Glen Burnie, Maryland, 21061, United States

Location

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Rockville, Maryland, 20852, United States

Location

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Belmont, Massachusetts, 02478, United States

Location

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Fall River, Massachusetts, 02721, United States

Location

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Farmington Hills, Michigan, 48336, United States

Location

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Nashua, New Hampshire, 03060, United States

Location

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Cherry Hill, New Jersey, 08002, United States

Location

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Piscataway, New Jersey, 08854-5635, United States

Location

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Brooklyn, New York, 11201, United States

Location

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New York, New York, 10024, United States

Location

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Staten Island, New York, 10312, United States

Location

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Chapel Hill, North Carolina, 27514, United States

Location

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Durham, North Carolina, 27710, United States

Location

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Columbus, Ohio, 43210, United States

Location

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Portland, Oregon, 97210, United States

Location

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Philadelphia, Pennsylvania, 19139, United States

Location

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Philadelphia, Pennsylvania, 19149, United States

Location

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Lincoln, Rhode Island, 02865, United States

Location

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Charleston, South Carolina, 29407, United States

Location

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Houston, Texas, 77057, United States

Location

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Richmond, Virginia, 23230, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98104, United States

Location

Pfizer Investigational Site

Middleton, Wisconsin, 53562, United States

Location

Related Links

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

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

imagabalin

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 16, 2012

Record last verified: 2012-11

Locations

US (43)