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

NCT00658762 | Terminated Phase 3

• 1 other identifier: A5361020
• Study Type: interventional
• Target: 286
• Locations: 2 countries
• Sites: 28

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.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in HAM-A total score at Week 8

  8 weeks

• To assess the safety and tolerability of PD 0332334 in subjects with GAD

  8 weeks with taper

Secondary Outcomes (19)

• Response rate on the HAM-A at Week 1 and Week 8

  8 weeks

• Remission rate based on the HAM-A at Week 8

  8 weeks

• Change from Baseline in the somatic subscale score of the HAM-A (item 7-13) at Week 8

  8 weeks

• Change from Baseline to Week 8 on the Medical Outcomes Study - Sleep Scale subscales

  8 weeks

• Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ).

  8 weeks

Study Arms (4)

PD 0332334 225 mg BID

EXPERIMENTAL

Drug: PD 0332334

PD 0332334 300 mg BID

EXPERIMENTAL

Drug: PD 0332334

Paroxetine 20 mg q am

ACTIVE COMPARATOR

Drug: paroxetine

Placebo BID

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PD 0332334 DRUG

Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper

Also known as: imagabalin

PD 0332334 225 mg BID

paroxetine DRUG

Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper

Paroxetine 20 mg q am

Placebo DRUG

Capsules, oral, BID, 8 weeks, with 2 week taper

Placebo BID

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (28)

Pfizer Investigational Site

Birmingham, Alabama, 35226, United States

Location

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Pfizer Investigational Site

Orange, California, 92868, United States

Location

Pfizer Investigational Site

Temecula, California, 92591, United States

Location

Pfizer Investigational Site

Upland, California, 91786, United States

Location

Pfizer Investigational Site

Wildomar, California, 92595, United States

Location

Pfizer Investigational Site

Fort Myers, Florida, 33912, United States

Location

Pfizer Investigational Site

Orange City, Florida, 32763, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30328, United States

Location

Pfizer Investigational Site

Marietta, Georgia, 30060, United States

Location

Pfizer Investigational Site

Greenwood, Indiana, 46143, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67207, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68131, United States

Location

Pfizer Investigational Site

New York, New York, 10021-4256, United States

Location

Pfizer Investigational Site

Syracuse, New York, 13210, United States

Location

Pfizer Investigational Site

Beachwood, Ohio, 44122, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45227, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44109-1998, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73116, United States

Location

Pfizer Investigational Site

Salem, Oregon, 97301, United States

Location

Pfizer Investigational Site

Media, Pennsylvania, 19063, United States

Location

Pfizer Investigational Site

Norristown, Pennsylvania, 19401, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Pfizer Investigational Site

Houston, Texas, 77008, United States

Location

Pfizer Investigational Site

Houston, Texas, 77074, United States

Location

Pfizer Investigational Site

Woodstock, Vermont, 05091, United States

Location

Pfizer Investigational Site

Budapest, 1135, Hungary

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

imagabalin; Paroxetine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 15, 2008
• Study Start: May 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: November 16, 2012

Record last verified: 2012-11

Locations

US (27); HU (1)