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

Primary Purpose

Depressive Disorders, Psychotic Disorders, Depression

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SCH 900636

Placebo

About this trial

This is an interventional treatment trial for Depressive Disorders

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Org 34517

Placebo

Arm Description

Org 34517 titrated to 900 mg daily for 2 weeks

Outcomes

Primary Outcome Measures

Safety and tolerability measures (vital signs, AEs)

Secondary Outcome Measures

17-item Hamilton Rating Scale for Depression (HAMD) total score

proportion of BPRS 30% responders; proportion of subjects with sustained BPRS 30% response

proportion of HAMD 50% responders; proportion of subjects with sustained HAMD 50% response

clinical global impression (CGI)

PANNS total score

PANSS positive scale score, PANSS negative scale score, PANSS general psychopathology score

Full Information

NCT ID

NCT00844922

First Posted

February 11, 2009

Last Updated

December 30, 2014

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00844922

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorders, Psychotic Disorders, Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Org 34517

Arm Type

Experimental

Arm Description

Org 34517 titrated to 900 mg daily for 2 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

SCH 900636

Other Intervention Name(s)

Org 34517

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Safety and tolerability measures (vital signs, AEs)

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

17-item Hamilton Rating Scale for Depression (HAMD) total score

Time Frame

4 weeks

Title

proportion of BPRS 30% responders; proportion of subjects with sustained BPRS 30% response

Time Frame

4 weeks

Title

proportion of HAMD 50% responders; proportion of subjects with sustained HAMD 50% response

Time Frame

4 weeks

Title

clinical global impression (CGI)

Time Frame

4 weeks

Title

PANNS total score

Time Frame

4 weeks

Title

PANSS positive scale score, PANSS negative scale score, PANSS general psychopathology score

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

12. IPD Sharing Statement

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

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