Clinical trial NCT00542685: A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder
Official title: A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group, 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-11
Enrollment: 551
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 study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.


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: The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment.
timeFrame: 8 weeks
measure: The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study.
timeFrame: 8 weeks
Secondary outcomes:
measure: Response rate on the clinician-rated 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 (MOSS-SS) subscales.
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 to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score).
timeFrame: 8 weeks
measure: Response rate on the HAM-A at Week 1 and Week 8.
timeFrame: 8 weeks
measure: Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8.
timeFrame: 8 weeks
measure: Remission rate based on the HAM-A at Week 1 and Week 8.
timeFrame: 8 weeks
measure: Response rate on the patient-rated PGI-C at Week 8.
timeFrame: 8 weeks
measure: The "Week 1 Sustained Responder" rate based on the HAM-A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM-A total score at Week 1 that is sustained until the Week 8 visit).
timeFrame: 1 week
measure: Change from Baseline in HAM-A total score at Weeks 1, 2, 4, and 6.
timeFrame: 6 weeks
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 to Week 8 on the Sheehan Disability Scale subscales.
timeFrame: 8 weeks
measure: Change from Baseline in CGI-S at Week 8.
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 Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) 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) total score.
timeFrame: 1 week
measure: Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary).
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Encino
country: United States
facility: Pfizer Investigational Site
state: California
city: National City
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Sherman Oaks
country: United States
facility: Pfizer Investigational Site
state: California
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Libertyville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Schaumburg
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Lafayette
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Owensboro
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Lake Charles
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Glen Burnie
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Rockville
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Belmont
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Fall River
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Nashua
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Cherry Hill
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Piscataway
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Staten Island
country: United States
facility: Pfizer Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Middleton
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: