Clinical trial NCT00658372: A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2)
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
Keywords: PD 0332334 phase 3 pivotal trial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-15
Enrollment: 360
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 to 65, with generalized anxiety disorder.

Detailed description: 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 diagnosis: 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: Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline 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: Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales
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 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 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score
timeFrame: 8 weeks
measure: Response rate on the HAM-A at week 1 and week 8
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 the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8
timeFrame: 8 weeks
measure: Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)
timeFrame: 8 weeks
measure: Change from baseline to week 8 in the QLesQ General Activity Score
timeFrame: 8 weeks
measure: Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)
timeFrame: 8 weeks
measure: Remission rate based on the HAM A at Week 8
timeFrame: 8 weeks
measure: Response rate on the clinician-rated CGI-I ate week 1 and week 8
timeFrame: 8 weeks
measure: Change from baseline in CGI-S at week 8
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: Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Pfizer Investigational Site
state: California
city: Costa Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Escondido
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Hamden
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Naperville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Park Ridge
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Prairie Village
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Haverhill
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Pittsfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Flint
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Flint
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: St. Paul
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Olean
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Bartlett
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: