A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: PD 0332334 Drug: paroxetine Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from Baseline in HAM-A total score at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To assess the safety and tolerability of PD 0332334 in subjects with GAD [ Time Frame: 8 weeks with taper ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response rate on the HAM-A at Week 1 and Week 8 [ 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 the somatic subscale score of the HAM-A (item 7-13) at Week 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 ]
Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ). [ 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 in the HAM-A total score at Weeks 1, 2, 4 and 6) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Response rate on the PGI-C at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Response rate on the CGI-I at Week 1 and Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score [ 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 ]
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 ]
The "Week 1 Sustained Responser" rate based on the HAM-A [ 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 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 in the Q-Les-Q General Activities Score [ 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 Disturbance Score [ Time Frame: 1 week ] [ 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 in CGI-S at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	286
Study Start Date:	May 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PD 0332334 225 mg BID	Drug: PD 0332334 Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper Other Name: imagabalin
Experimental: PD 0332334 300 mg BID	Drug: PD 0332334 Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper
Active Comparator: Paroxetine 20 mg q am	Drug: paroxetine Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper
Placebo Comparator: Placebo BID	Drug: Placebo Capsules, oral, BID, 8 weeks, with 2 week taper

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

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658762

Show 28 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00658762 History of Changes
Other Study ID Numbers:	A5361020
Study First Received:	April 9, 2008
Last Updated:	November 9, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013