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

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 to 65, with generalized anxiety disorder.

Detailed Description
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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 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.

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: Quadruple


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 QD<br> | Drug: Paroxetine<br>* Capsules, oral, Paroxetine, 20 mg QD, 8 weeks with 2 week taper<br>|
| Placebo Comparator: Placebo BID<br> | Drug: Placebo<br>* Capsules, oral, placebo, 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 |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score |  | 8 weeks | 
| Response rate on the HAM-A at week 1 and week 8 |  | 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 the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8 |  | 8 weeks | 
| Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13) |  | 8 weeks | 
| Change from baseline to week 8 in the QLesQ General Activity Score |  | 8 weeks | 
| Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ) |  | 8 weeks | 
| Remission rate based on the HAM A at Week 8 |  | 8 weeks | 
| Response rate on the clinician-rated CGI-I ate week 1 and week 8 |  | 8 weeks | 
| Change from baseline in CGI-S at week 8 |  | 8 weeks | 
| Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary) |  | 8 weeks | 
| Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD 0332334 phase 3 pivotal trial