A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of PRX-00023 in Patients With Major Depressive Disorder.
Overview
- Phase
- Phase 2
- Intervention
- PRX-00023
- Conditions
- Major Depressive Disorder (MDD)
- Sponsor
- Epix Pharmaceuticals, Inc.
- Enrollment
- 330
- Locations
- 19
- Primary Endpoint
- Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of major depressive disorder
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.
Arms & Interventions
1
PRX-00023 taken twice daily, escalating from 40 mg to 80 mg to 120 mg
Intervention: PRX-00023
2
Placebo taken twice daily, escalating from 40 mg to 80 mg to 120 mg
Intervention: Placebo for PRX-00023
Outcomes
Primary Outcomes
Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).
Time Frame: change from baseline through end of study
Secondary Outcomes
- 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)