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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Generalized Anxiety Disorder

Treatments: Drug: paroxetine; Drug: Placebo; Drug: PD 0332334

Study type: Interventional

Funder types: Industry

Identifiers

NCT00658762

A5361020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 286 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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286 participants in 4 patient groups, including a placebo group

PD 0332334 225 mg BID

Experimental group

Treatment:

Drug: PD 0332334

Drug: PD 0332334

PD 0332334 300 mg BID

Experimental group

Treatment:

Drug: PD 0332334

Drug: PD 0332334

Paroxetine 20 mg q am

Active Comparator group

Treatment:

Drug: paroxetine

Placebo BID

Placebo Comparator group

Treatment:

Drug: Placebo