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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Psychotic Disorders; Depressive Disorders
• Intervention / Treatment: Drug: Placebo; Drug: SCH 900636

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• have attended Screening, Baseline, Visit Day 15, Day 29 and Day 43 of previous trial 28130;
• have a CGI of Severity score of 3 or greater at Day 43 of previous trial 28130 and at Day 1 of current trial 28133, or a lower score when the investigator is of the opinion that further resolution of symptoms is warranted;
• be on a stable dose of 'usual treatment', which must consist of an antidepressant, an antipsychotic, a mood stabilizer or any combination of these 3 drug classes.

Exclusion Criteria:

• had experienced any of the following significant safety outcomes in previous trial 28130:

  • severe breakthrough bleeding;
  • diagnosis of prostatitis;
  • abnormal level of testosterone at Day 15 of previous trial 28130;
  • any adverse event deemed relevant for exclusion in trial 28133 by the investigator.
• had an abnormal PSA test at Day -7 of previous trial 28133
• were at significant risk of committing suicide, as indicated by a score greater than 9 on the revised ISST at Day -7 or Day 1;
• were currently treated with carbamazepine or valproate, midazolam, or clozapine;
• had been treated with electroconvulsive therapy (ECT) in the current episode;
• were currently treated with more than one antidepressant, antipsychotic, or mood stabilizer;
• had 'usual treatment' started or discontinued in the 2 weeks before Day 1;
• had a 'usual treatment' dose change within one week prior to Day 1;
• had any clinically unstable or uncontrollable renal, hepatic, respiratory, hematological, cardiovascular or cerebrovascular disease that would put the patient at risk of safety or bias assessment of efficacy;
• had known hypersensitivity reactions to glucocorticoid antagonists;
• had any clinically significant abnormal laboratory data (e.g. aspartate amino transferase (ASAT) and/or alanine amino transferase (ALAT) values > 2x normal range upper limit) or ECG results, or a clinically significant abnormal outcome at the physical examination at Day -7;
• had a confirmed positive result on the drug screening test for any illicit drug, except cannabis, at Day -7;
• had any untreated or uncompensated clinically significant endocrine disorder;
• were using hormone replacement therapy at Day -7;
• required concomitant treatment with corticosteroids (topical use was allowed);
• women of childbearing potential without adequate contraception
• women with a positive pregnancy test at Day -7 or 1, or are breast feeding mothers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
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 Names: Org 34517

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability measures (vital signs, AEs)	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
17-item Hamilton Rating Scale for Depression (HAMD) total score	4 weeks
proportion of BPRS 30% responders; proportion of subjects with sustained BPRS 30% response	4 weeks
proportion of HAMD 50% responders; proportion of subjects with sustained HAMD 50% response	4 weeks
clinical global impression (CGI)	4 weeks
PANNS total score	4 weeks
PANSS positive scale score, PANSS negative scale score, PANSS general psychopathology score	4 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: February 11, 2009
• First Submitted That Met QC Criteria: February 13, 2009
• First Posted (Estimate): February 16, 2009

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 30, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depression; Depressive Disorder; Disease; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: P05842; EudraCT #: 2004-002156-34