A Efficacy Study of PRX-00023 in Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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The purpose of this randomized, double-blind, placebo-controlled study is to assess the safety and efficacy of PRX-00023 in patients with major depressive disorder.

Detailed Description
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Patients with major depressive disorder who meet all of the eligibility criteria will be randomly assigned to receive twice daily doses of either placebo or PRX-00023. Study drug will be taken for up to approximately 9 weeks. Patients will have periodic office visits for the purpose of monitoring safety and tolerability, as well as efficacy assessments.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of PRX-00023 in Patients With Major Depressive Disorder.

Conditions
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Major Depressive Disorder (MDD)

Intervention / Treatment
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* Drug: PRX-00023
* Drug: Placebo for PRX-00023


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Diagnosis of major depressive disorder Key Exclusion Criteria: Females who are pregnant or nursing Electroconvulsive therapy within previous year Type 1 diabetes or uncontrolled type 2 diabetes HIV, Hepatitis B or Hepatitis C Use of illegal drugs, history of drug abuse, and/or alcohol dependence Clinically significant abnormal lab results Other protocol-defined eligibility criteria may apply.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PRX-00023 taken twice daily, escalating from 40 mg to 80 mg to 120 mg | Drug: PRX-00023<br>* Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.<br>|
| Placebo Comparator: 2<br>Placebo taken twice daily, escalating from 40 mg to 80 mg to 120 mg | Drug: Placebo for PRX-00023<br>* Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS). |  | change from baseline through end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects during and immediately following the treatment period |  | assessed throughout study | 
| changes from baseline on the Hamilton Anxiety Rating (HAM-A) scale |  | change from baseline through end of study | 
| changes from baseline on the Quick Inventory of Depressive Symptomatology-self report (QIDS-SR) |  | change from baseline through end of study | 
| changes from baseline on the Clinical Global Impressions (CGI) scale |  | change from baseline through end of study | 
| responder and remission rates |  | change from baseline through end of study | 
| changes from baseline on the Changes in Sexual Function (CSFQ) scale. |  | change from baseline through end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Major Depressive Disorder, Major Depression, MDD