Generalized Anxiety Disorder
Conditions
Keywords
Generalized Anxiety Disorder Elderly
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.
Interventions
DRUGPD-0332334
Dosage from: 50-100 mg oral capsule Dosage and frequency: 50-350 mg once or twice a day Duration: 6 months
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electrocardiograms will be performed to assess any changes in cardiac functioning related to the compound | Screening, Baseline, Wk 4, Wk 15 & Wk 26/EOT |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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) |
Countries
United States
Outcome results
None listed