6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD)

Last updated: November 30, 2012
Sponsor: Pfizer
Overall Status: Trial Not Available

Phase

3

Condition

Anxiety Disorders

Panic Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00738738
A5361036
  • Ages > 65
  • All Genders

Study Summary

This is an open-label, multi-site, 6-month study of an investigational compound in elderly outpatients, age 65 years old or above, to assess the long-term safety and tolerability of the compound in the treatment of elderly subjects with Generalized Anxiety Disorder (GAD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men or women age > 65 years.

  • A primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic andStatistical Manual-IV (DSM-IV).

  • Subjects must have a HAM-A score of 16 or higher at both screening and baselinevisits.

Exclusion

Exclusion Criteria:

  • Women who are pregnant or contemplating pregnancy (eg, via in vitro fertilization)during the study through 30 days after the last dose of study medication.

  • Subjects with evidence of a current (within the past 6 months) clinically significantor unstable hematological, autoimmune, renal, endocrine, pulmonary, gastrointestinal,cardiovascular, hepatic, pancreatic, psychiatric, neurologic, immunological or retinaldisorder; subjects with an active infection within the past 2 months.

  • Subjects who have an ongoing, unresolved, clinically significant cardiovascular orcerebrovascular medical problem.

  • Mini Mental Status Exam (MMSE) score <24 or possibility of undiagnosed dementia,cognitive or amnestic disorder, including, but not limited to mild cognitiveimpairment.

Study Design

Study Start date:
January 01, 2009
Estimated Completion Date:
February 28, 2009

Study 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.

Connect with a study center

  • Pfizer Investigational Site

    Orlando, Florida 32806
    United States

    Site Not Available

  • Pfizer Investigational Site

    Prairie Village, Kansas 66206
    United States

    Site Not Available

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