Clinical trial NCT00738738: 6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD)
Official title: A Phase 3, 6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder Elderly
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-20
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication
timeFrame: Weekly
measure: The nature, incidence, duration, and severity of adverse events.
timeFrame: Weekly
measure: Suicide related adverse events will be further assessed using the Columbia Suicide Severity Rating Scale as needed
timeFrame: As needed
measure: 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
timeFrame: Screening, Baseline, Wk 4, Wk 14, Wk 26/EOT, & at FU; Vital signs at every vist
measure: Electrocardiograms will be performed to assess any changes in cardiac functioning related to the compound
timeFrame: Screening, Baseline, Wk 4, Wk 15 & Wk 26/EOT
Secondary outcomes:
measure: Symptom severity of generalized Anxiety Disorder (GAD) will be measured by the Hamilton Rating Scale for Anxiety (HAM-A).
timeFrame: Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT & Wk 27 (FU)
measure: Overall Health Care utilization will be assessed with the Health Care Utilization (HCU) questionnaire.
timeFrame: Twice at Wk 13 and Wk 26/EOT
measure: 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.
timeFrame: Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT
measure: Plasma concentrations will be collected to evaluate the population pharmacokinetics and the dose/exposure relationships for safety and efficacy .
timeFrame: 1 time
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Prairie Village
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: