Clinical trial NCT00658762: A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)
Official title: A Phase 3, Randomized, Double-Blind, Parallel Group, 10-Week Placebo Controlled Fixed Dose Study of PD 0332334 and Paroxetine Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-15
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects ages 18 and older with generalized anxiety disorder.

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:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in HAM-A total score at Week 8
timeFrame: 8 weeks
measure: To assess the safety and tolerability of PD 0332334 in subjects with GAD
timeFrame: 8 weeks with taper
Secondary outcomes:
measure: Response rate on the HAM-A at Week 1 and Week 8
timeFrame: 8 weeks
measure: Remission rate based on the HAM-A at Week 8
timeFrame: 8 weeks
measure: Change from Baseline in the somatic subscale score of the HAM-A (item 7-13) at Week 8
timeFrame: 8 weeks
measure: Change from Baseline to Week 8 on the Medical Outcomes Study - Sleep Scale subscales
timeFrame: 8 weeks
measure: Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ).
timeFrame: 8 weeks
measure: Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score
timeFrame: 8 weeks
measure: Change from Baseline in the HAM-A total score at Weeks 1, 2, 4 and 6)
timeFrame: 6 weeks
measure: Response rate on the PGI-C at Week 8
timeFrame: 8 weeks
measure: Response rate on the CGI-I at Week 1 and Week 8
timeFrame: 8 weeks
measure: Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score
timeFrame: 8 weeks
measure: Average (across the Week 1, 2, 4, 6 and 8 visits) HAM-A Change from Baseline score
timeFrame: 8 weeks
measure: Change from Baseline to Days 2-8 and Weeks 2, 4, 6 and 8 on the GA-VAS (diary)
timeFrame: 8 weeks
measure: The "Week 1 Sustained Responser" rate based on the HAM-A
timeFrame: 8 weeks
measure: Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8.
timeFrame: 8 weeks
measure: Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score)
timeFrame: 8 weeks
measure: Change from Baseline to Week 8 in the Q-Les-Q General Activities Score
timeFrame: 8 weeks
measure: Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score
timeFrame: 1 week
measure: Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8
timeFrame: 8 weeks
measure: Change from Baseline in CGI-S at Week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Temecula
country: United States
facility: Pfizer Investigational Site
state: California
city: Upland
country: United States
facility: Pfizer Investigational Site
state: California
city: Wildomar
country: United States
facility: Pfizer Investigational Site
state: California
city: Ft. Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orange City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Greenwood
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Beachwood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Salem
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Media
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Norristown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Woodstock
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: