NCT00844922

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive Disorders
• Psychotic Disorders
• Depression

Interventions

Type	Name	Description
DRUG	SCH 900636	Org 34517 300 mg on Day 1, 600 mg on Day 2, then 900 mg daily starting from Day 3. Subjects in this arm were also to continue the "usual treatment" for psychotic major depression.
DRUG	Placebo	Placebo

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2009-02-16
• Last updated: 2014-12-31