Fixed Dose Study of PD 0332334 and Paroxetine for the Treatment of Generalized Anxiety Disorder

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Anxiety Disorders

In brief

This study is a randomized, double-blind, parallel-group, multi-site, Phase 3, placebo controlled fixed-dose study of PD 0332334 and paroxetine in 528 outpatients with generalized anxiety disorder. Subjects will be randomized to the following treatments (132 subjects per treatment group): PD 0332334 225 mg twice a day (450 mg/day), PD 0332334 300 mg twice a day (600 mg/day), placebo once a day in the morning or paroxetine 20 mg once a day in the morning (20 mg/day).

Key facts

Study ID

NCT00836069

Run by

Cedars-Sinai Medical Center

People needed

5

Starts

2008-10-01

Expected to finish

2010-04-01

Last updated by the study team

2019-08-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
• Diagnosis of generalized anxiety disorder (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) as established by the clinician.
• Subjects must have a Hamilton-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.
• Otherwise healthy men or non-pregnant, non-lactating women (women must be using a hormonal or barrier method of contraception or be postmenopausal or surgically sterilized). Healthy is defined as no other clinically relevant abnormalities identified by a detailed medical history, full physical examination including sitting blood pressure and heart rate measurement, 12-lead ECG, and clinical laboratory tests.
• Age 18 to 65 years, inclusive.
• All women must have negative pregnancy tests at the Screening (Visit 1) and Randomization (Visit 2) visits.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if…

• Subjects presenting with any of the following will not be included in the study:
• 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) Diagnostic and Statistical Manual of Mental Disorders-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 Diagnostic and Statistical Manual of Mental Disorders-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. (Note: The Suicidality module of the Mini-Mental State Examination diagnostic interview and the Columbia-Suicide Severity Rating Scale should be used as aids to the assessment of suicidality, but do not replace overall clinical judgment in determination of suicidal risk).
• Current use of psychotropic medications (ie, drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that cannot be discontinued 2 weeks prior to randomization. Fluoxetine is prohibited within 5 weeks of randomization. In the event of inadvertent administration of psychotropic medications during the 2 weeks prior to randomization, continued eligibility will be assessed on a case by case basis by the investigator and the medical monitor.
• Use of drugs, supplements, prescription or nonprescription, or food that have psychoactive properties. In the event of inadvertent use of such products during the 2 weeks prior to randomization, continued eligibility will be assessed on a case by case basis by the investigator and the medical monitor. In addition, following a discussion of the individual case between the medical monitor and the investigator, the medical monitor may allow minimal anxiolytic medication (for example a benzodiazepine) use for subjects who experience significant intolerable anxiety during the final week of the study (Days 64-71).
• Subjects who have been treated with monoamine oxidase inhibitors in the 14 days prior to the baseline visit.

Where it is running

• Cedars-Sinai Medical Center Department of Psychiatry and Behavioral Neurosciences — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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