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

NCT00658008 | Terminated Phase 3

• 1 other identifier: A5361019
• Study Type: interventional
• Target: 501
• Locations: 5 countries
• Sites: 52

Brief Summary

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.

Conditions

Generalized Anxiety Disorder

Keywords

PD 0332334 phase 3 pivotal trial

Outcome Measures

Primary Outcomes (2)

• 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.

  8 weeks

• The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study

  8 weeks

Secondary Outcomes (20)

• Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)

  8 weeks

• Response rate on the patient-rated PGI-C at week 8

  8 weeks

• Change from baseline to week 8 on the Sheehan Disability Scale subscales

  8 weeks

• Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)

  8 weeks

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

  8 weeks

Study Arms (5)

PD 0332334 175 mg BID

EXPERIMENTAL

Drug: PD 0332334

PD 0332334 225 mg BID

EXPERIMENTAL

Drug: PD 0332334

PD 0332334 75 mg BID

EXPERIMENTAL

Drug: PD 0332334

Paroxetine 20 mg QD

ACTIVE COMPARATOR

Drug: Paroxetine

Placebo BID

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PD 0332334 DRUG

Capsules, oral, 175 mg BID, 8 weeks with 2 week taper

Also known as: imagabalin

PD 0332334 175 mg BID

Paroxetine DRUG

Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper

Paroxetine 20 mg QD

Placebo DRUG

Capsules, oral, placebo 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 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (52)

Pfizer Investigational Site

Litchfield Park, Arizona, 85340, United States

Location

Pfizer Investigational Site

Costa Mesa, California, 92626, United States

Location

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Pasadena, California, 91106, United States

Location

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Redlands, California, 92374, United States

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Denver, Colorado, 80239, United States

Location

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Norwich, Connecticut, 06360, United States

Location

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Altamonte Springs, Florida, 32701, United States

Location

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Maitland, Florida, 32751, United States

Location

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Miami, Florida, 33126, United States

Location

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Miami, Florida, 33143, United States

Location

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South Miami, Florida, 33143, United States

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Terre Haute, Indiana, 47802, United States

Location

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Overland Park, Kansas, 66212, United States

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Topeka, Kansas, 66606, United States

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Shreveport, Louisiana, 71104, United States

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Baltimore, Maryland, 21208, United States

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Boston, Massachusetts, 02135, United States

Location

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Saint Charles, Missouri, 63301, United States

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Las Vegas, Nevada, 89146, United States

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Clementon, New Jersey, 08021, United States

Location

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Willingboro, New Jersey, 08046, United States

Location

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Albuquerque, New Mexico, 87109, United States

Location

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Brooklyn, New York, 11235, United States

Location

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New York, New York, 10023, United States

Location

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The Bronx, New York, 10454, United States

Location

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The Bronx, New York, 10467, United States

Location

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Raleigh, North Carolina, 27607, United States

Location

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Toledo, Ohio, 43609, United States

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Toledo, Ohio, 43623, United States

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Bethany, Oklahoma, 73008, United States

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Bala-Cynwyd, Pennsylvania, 19004, United States

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Media, Pennsylvania, 19063, United States

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Norristown, Pennsylvania, 19401, United States

Location

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19136, United States

Location

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Columbia, South Carolina, 29201, United States

Location

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Memphis, Tennessee, 38117, United States

Location

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Austin, Texas, 78756, United States

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Dallas, Texas, 75231, United States

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Lake Jackson, Texas, 77566, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Burlington, Vermont, 05401, United States

Location

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Charlottesville, Virginia, 22903, United States

Location

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Charlottesville, Virginia, 22911, United States

Location

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Waukesha, Wisconsin, 53188-1660, United States

Location

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Budapest, 1095, Hungary

Location

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Budapest, 1137, Hungary

Location

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Catania, 95123, Italy

Location

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Torino, 10126, Italy

Location

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Khotkovo, Moscow Region, 142601, Russia

Location

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Seoul, 135-710, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 16, 2012

Record last verified: 2012-11

Locations

RU (1); US (45); HU (2); IT (2); KR (2)