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Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)

Depression Clinical Trial

Official title:
Double-blind, Placebo-controlled Trial Investigating the Safety of Re-exposure to 900 mg of Org 34517, Used as Adjunctive Therapy in Subjects With Psychotic Major Depression (Major Depressive Episode, Severe, With Psychotic Features), Who Participated in Trial 28130

Clinical Trial Summary

Patients who participated in the previous trial 28130, who were eligible, were entered into this trial. Patients who were randomized to placebo in the previous trial 28130 continued on placebo while patients who were randomized to Org 34517 (SCH 900636), regardless of dose, were titrated to 900 mg Org 34517. Patients in this trial took their study medication for 2 weeks in order to study the safety and tolerability of Org 34517.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00844922
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Completed
Phase Phase 2
Start date September 2005
Completion date June 2006
View Details
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