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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00844922
First received: February 11, 2009
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Depressive Disorders
Psychotic Disorders
Depression
Drug: SCH 900636
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Safety and tolerability measures (vital signs, AEs) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 17-item Hamilton Rating Scale for Depression (HAMD) total score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • proportion of BPRS 30% responders; proportion of subjects with sustained BPRS 30% response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • proportion of HAMD 50% responders; proportion of subjects with sustained HAMD 50% response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • clinical global impression (CGI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • PANNS total score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • PANSS positive scale score, PANSS negative scale score, PANSS general psychopathology score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: September 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00844922     History of Changes
Other Study ID Numbers: P05842, EudraCT #: 2004-002156-34;, P05842
Study First Received: February 11, 2009
Last Updated: September 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Psychotic Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 26, 2014