A 10-Week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1) - Full Text View

Purpose

This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages from 18 to 65, with generalized anxiety disorder.

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: PD 0332334 Drug: Paroxetine Drug: Placebo	Phase III

MedlinePlus related topics:

Anxiety

ChemIDplus related topics:

Paroxetine Paroxetine hydrochloride Paroxetine Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Response rate on the patient-rated PGI-C at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 8 on the Sheehan Disability Scale subscales [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Response rate on the HAM-A at week 1 and week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Response rate on the clinician-rated CGI-I ate week 1 and week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Remission rate based on the HAM A at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in CGI-S at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 8 in the QLesQ General Activity Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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). [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Change from Baseline to Days 2 8 and Weeks 2, 4, 6, 8 on the DAS A (total score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	685
Study Start Date:	April 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PD 0332334 225 mg BID: Experimental	Drug: PD 0332334 Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
PD 0332334 175 mg BID: Experimental	Drug: PD 0332334 Capsules, oral, 175 mg BID, 8 weeks with 2 week taper
PD 0332334 75 mg BID: Experimental	Drug: PD 0332334 Capsules, oral, 75 mg BID, 8 weeks with 2 week taper
Paroxetine 20 mg QD: Active Comparator	Drug: Paroxetine Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper
Placebo BID: Placebo Comparator	Drug: Placebo Capsules, oral, placebo bid, 8 weeks with 2 week taper

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658008

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 46 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5361019
First Received:	April 8, 2008
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00658008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

PD 0332334 phase 3 pivotal trial

Study placed in the following topic categories:

Anxiety Disorders

Mental Disorders

Paroxetine

Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Disease

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Serotonin Uptake Inhibitors

Pharmacologic Actions

Pathologic Processes

Serotonin Agents

Therapeutic Uses

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on August 21, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00658008