A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.

Official Title
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A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group, 10-Week Study 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: Placebo
* Drug: PD 0332334
* Drug: PD 0332334


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 300 mg BID<br> | Drug: PD 0332334<br>* Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.<br>* Other names: imagabalin;|
| Placebo Comparator: Placebo BID<br> | Drug: Placebo<br>* Capsules, oral, placebo BID, 8 weeks with 2 week taper.<br>|
| Experimental: PD 0332334 225 mg BID<br> | Drug: PD 0332334<br>* Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.<br>|
| Experimental: PD 0332334 175 mg BID<br> | Drug: PD 0332334<br>* Capsules, oral, 175 mg 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 |
| --- | --- | --- |
| Response rate on the clinician-rated CGI-I at Week 1 and Week 8. |  | 8 weeks | 
| Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales. |  | 8 weeks | 
| Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score. |  | 8 weeks | 
| Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score). |  | 8 weeks | 
| Response rate on the HAM-A at Week 1 and Week 8. |  | 8 weeks | 
| Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8. |  | 8 weeks | 
| Remission rate based on the HAM-A at Week 1 and Week 8. |  | 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 in HAM-A total score at Weeks 1, 2, 4, and 6. |  | 6 weeks | 
| Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8. |  | 8 weeks | 
| Change from Baseline to Week 8 on the Sheehan Disability Scale subscales. |  | 8 weeks | 
| Change from Baseline in CGI-S at Week 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 to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) 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) total score. |  | 1 week | 
| Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary). |  | 8 weeks |