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

A Phase 3, 6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder

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).

Study Overview

• Status: Withdrawn
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Drug: PD-0332334

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
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Pfizer Investigational Site
  • Kansas
    • Prairie Village, Kansas, United States, 66206
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women age > 65 years.
• A primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual-IV (DSM-IV).
• Subjects must have a HAM-A score of 16 or higher at both screening and baseline visits.

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 significant or unstable hematological, autoimmune, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, immunological or retinal disorder; subjects with an active infection within the past 2 months.
• Subjects who have an ongoing, unresolved, clinically significant cardiovascular or cerebrovascular medical problem.
• Mini Mental Status Exam (MMSE) score <24 or possibility of undiagnosed dementia, cognitive or amnestic disorder, including, but not limited to mild cognitive impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication	Weekly
The nature, incidence, duration, and severity of adverse events.	Weekly
Suicide related adverse events will be further assessed using the Columbia Suicide Severity Rating Scale as needed	As needed
The primary outcome is safety which will be assessed throughout the 6-months by physical exams, monitoring of vital signs, body weight changes, and clinical safety laboratory	Screening, Baseline, Wk 4, Wk 14, Wk 26/EOT, & at FU; Vital signs at every vist
Electrocardiograms will be performed to assess any changes in cardiac functioning related to the compound	Screening, Baseline, Wk 4, Wk 15 & Wk 26/EOT

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptom severity of generalized Anxiety Disorder (GAD) will be measured by the Hamilton Rating Scale for Anxiety (HAM-A).	Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT & Wk 27 (FU)
Overall Health Care utilization will be assessed with the Health Care Utilization (HCU) questionnaire.	Twice at Wk 13 and Wk 26/EOT
Also, the Daily Diary (including the Daily assessment of Symptoms DAS-A and Global Anxiety - Visual Analog Scale (GA-VAS) and the Clinical Global Impression of Severity (CGI-S) will be used to assess symptoms of GAD.	Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT
Plasma concentrations will be collected to evaluate the population pharmacokinetics and the dose/exposure relationships for safety and efficacy .	1 time

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: January 1, 2009
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: August 12, 2008
• First Submitted That Met QC Criteria: August 18, 2008
• First Posted (Estimate): August 20, 2008

Study Record Updates

• Last Update Posted (Estimate): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 30, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Generalized Anxiety Disorder Elderly
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders
• Other Study ID Numbers: A5361036