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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 3, Randomized, Double-Blind, Parallel Group, 10-Week Placebo Controlled Fixed Dose Study of PD 0332334 and Paroxetine Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Drug: PD 0332334
* Drug: PD 0332334
* Drug: paroxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD 0332334 225 mg BID<br> | Drug: PD 0332334<br>* Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper<br>* Other names: imagabalin;|
| Experimental: PD 0332334 300 mg BID<br> | Drug: PD 0332334<br>* Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper<br>|
| Active Comparator: Paroxetine 20 mg q am<br> | Drug: paroxetine<br>* Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper<br>|
| Placebo Comparator: Placebo BID<br> | Drug: Placebo<br>* Capsules, oral, BID, 8 weeks, with 2 week taper<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in HAM-A total score at Week 8 |  | 8 weeks | 
| To assess the safety and tolerability of PD 0332334 in subjects with GAD |  | 8 weeks with taper | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate on the HAM-A at Week 1 and Week 8 |  | 8 weeks | 
| Remission rate based on the HAM-A at Week 8 |  | 8 weeks | 
| Change from Baseline in the somatic subscale score of the HAM-A (item 7-13) at Week 8 |  | 8 weeks | 
| Change from Baseline to Week 8 on the Medical Outcomes Study - Sleep Scale subscales |  | 8 weeks | 
| Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ). |  | 8 weeks | 
| Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score |  | 8 weeks | 
| Change from Baseline in the HAM-A total score at Weeks 1, 2, 4 and 6) |  | 6 weeks | 
| Response rate on the PGI-C at Week 8 |  | 8 weeks | 
| Response rate on the CGI-I at Week 1 and Week 8 |  | 8 weeks | 
| Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score |  | 8 weeks | 
| Average (across the Week 1, 2, 4, 6 and 8 visits) HAM-A Change from Baseline score |  | 8 weeks | 
| Change from Baseline to Days 2-8 and Weeks 2, 4, 6 and 8 on the GA-VAS (diary) |  | 8 weeks | 
| The Week 1 Sustained Responser rate based on the HAM-A |  | 8 weeks | 
| Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8. |  | 8 weeks | 
| Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score) |  | 8 weeks | 
| Change from Baseline to Week 8 in the Q-Les-Q General Activities Score |  | 8 weeks | 
| Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score |  | 1 week | 
| Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8 |  | 8 weeks | 
| Change from Baseline in CGI-S at Week 8 |  | 8 weeks |