A Phase 2 interventional study of PRX-00023 and Placebo for PRX-00023 in Major Depressive Disorder (MDD), sponsored by Epix Pharmaceuticals, Inc.. Completed at 21 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-11-14.
Sponsored by Epix Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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.
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 330 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Epix Pharmaceuticals, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined eligibility criteria may apply.
PRX-00023 taken twice daily, escalating from 40 mg to 80 mg to 120 mg
Drug: PRX-00023
Placebo taken twice daily, escalating from 40 mg to 80 mg to 120 mg
Drug: Placebo for PRX-00023
Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).
Time frame: change from baseline through end of study
Side effects during and immediately following the treatment period
Time frame: assessed throughout study
changes from baseline on the Hamilton Anxiety Rating (HAM-A) scale
Time frame: change from baseline through end of study
changes from baseline on the Quick Inventory of Depressive Symptomatology-self report (QIDS-SR)
Time frame: change from baseline through end of study
changes from baseline on the Clinical Global Impressions (CGI) scale
Time frame: change from baseline through end of study
responder and remission rates
Time frame: change from baseline through end of study
changes from baseline on the Changes in Sexual Function (CSFQ) scale.
Time frame: change from baseline through end of study
This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.
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Epix Pharmaceuticals, Inc.