Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: February 16, 2009
Last Update Posted: December 31, 2014
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Depressive Disorders Psychotic Disorders Depression||Drug: SCH 900636 Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
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Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Safety and tolerability measures (vital signs, AEs) [ Time Frame: 4 weeks ]
Secondary Outcome Measures:
- 17-item Hamilton Rating Scale for Depression (HAMD) total score [ Time Frame: 4 weeks ]
- proportion of BPRS 30% responders; proportion of subjects with sustained BPRS 30% response [ Time Frame: 4 weeks ]
- proportion of HAMD 50% responders; proportion of subjects with sustained HAMD 50% response [ Time Frame: 4 weeks ]
- clinical global impression (CGI) [ Time Frame: 4 weeks ]
- PANNS total score [ Time Frame: 4 weeks ]
- PANSS positive scale score, PANSS negative scale score, PANSS general psychopathology score [ Time Frame: 4 weeks ]
|Study Start Date:||September 2005|
|Study Completion Date:||June 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Experimental: Org 34517
Org 34517 titrated to 900 mg daily for 2 weeks
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.
Other Name: Org 34517
|Placebo Comparator: Placebo||
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