A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2)

NCT00658372 | Terminated Phase 3

• 1 other identifier: A5361018
• Study Type: interventional
• Target: 360
• Locations: 4 countries
• Sites: 33

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.

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 (19)

• Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score

  8 weeks

• Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6

  6 weeks

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

  8 weeks

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

  8 weeks

• 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)

  1 week

Study Arms (4)

PD 0332334 225 mg BID

EXPERIMENTAL

Drug: PD 0332334

PD 0332334 300 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, 225 mg BID, 8 weeks with 2 week taper

Also known as: imagabalin

PD 0332334 225 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 (33)

Pfizer Investigational Site

Arcadia, California, 91007-3462, United States

Location

Pfizer Investigational Site

Costa Mesa, California, 92627, United States

Location

Pfizer Investigational Site

Escondido, California, 92025, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90048, United States

Location

Pfizer Investigational Site

San Diego, California, 92108, United States

Location

Pfizer Investigational Site

Hamden, Connecticut, 06518, United States

Location

Pfizer Investigational Site

Boca Raton, Florida, 33431, United States

Location

Pfizer Investigational Site

Honolulu, Hawaii, 96813, United States

Location

Pfizer Investigational Site

Naperville, Illinois, 60563, United States

Location

Pfizer Investigational Site

Park Ridge, Illinois, 60068, United States

Location

Pfizer Investigational Site

Prairie Village, Kansas, 66206, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70115, United States

Location

Pfizer Investigational Site

Haverhill, Massachusetts, 01830, United States

Location

Pfizer Investigational Site

Pittsfield, Massachusetts, 01201, United States

Location

Pfizer Investigational Site

Flint, Michigan, 48503, United States

Location

Pfizer Investigational Site

Flint, Michigan, 48532, United States

Location

Pfizer Investigational Site

Minneapolis, Minnesota, 55454, United States

Location

Pfizer Investigational Site

Saint Paul, Minnesota, 55101, United States

Location

Pfizer Investigational Site

New York, New York, 10128-1708, United States

Location

Pfizer Investigational Site

Olean, New York, 14760, United States

Location

Pfizer Investigational Site

Rochester, New York, 14618, United States

Location

Pfizer Investigational Site

Dayton, Ohio, 45408, United States

Location

Pfizer Investigational Site

Allentown, Pennsylvania, 18104, United States

Location

Pfizer Investigational Site

Bartlett, Tennessee, 38134, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38119, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

DeSoto, Texas, 75115, United States

Location

Pfizer Investigational Site

Houston, Texas, 77090, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84132, United States

Location

Pfizer Investigational Site

Budapest, 1212, Hungary

Location

Pfizer Investigational Site

Moscow, 125367, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 191180, Russia

Location

Pfizer Investigational Site

Tainan, 704, Taiwan

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

Record last verified: 2012-11

Locations

RU (2); TW (1); HU (1); US (29)