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

NCT ID: NCT00844922

Last Updated: 2014-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-06-30

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.

Conditions

Depressive Disorders; Psychotic Disorders; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Org 34517

Org 34517 titrated to 900 mg daily for 2 weeks

Group Type: EXPERIMENTAL

SCH 900636

Intervention Type: DRUG

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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Org 34517

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EudraCT #: 2004-002156-34;

Identifier Type: -

Identifier Source: secondary_id

P05842

Identifier Type: -

Identifier Source: secondary_id

P05842

Identifier Type: -

Identifier Source: org_study_id