A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-07-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population

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Detailed Description

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Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PD 0332334 250 mg

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

250 mg capsule, BID for 4 weeks

PD 0332334 100 mg

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

100 mg capsule, BID for 4 weeks

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

0 mg capsule, BID for 4 weeks

Alprazolam extended release

Group Type ACTIVE_COMPARATOR

Alprazolam extended release

Intervention Type DRUG

1 mg capsule, BID for 4 weeks

Interventions

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PD 0332334

250 mg capsule, BID for 4 weeks

Intervention Type DRUG

PD 0332334

100 mg capsule, BID for 4 weeks

Intervention Type DRUG

placebo

0 mg capsule, BID for 4 weeks

Intervention Type DRUG

Alprazolam extended release

1 mg capsule, BID for 4 weeks

Intervention Type DRUG

Other Intervention Names

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imagabalin Xanax XR

Eligibility Criteria

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Inclusion Criteria

* Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD) (Diagnostic and Statistical Manual-IV \[DSM-IV\], 300.02).
* HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both Screening and Baseline/Randomization.

Exclusion Criteria

* Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder;
* Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder; Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder; Dissociative Disorders; Antisocial or borderline personality disorder
* Current use of psychotropic medications (i.e., drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No