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

NCT00844922 | Completed Phase 2 DMC

• 2 other identifiers: P05842EudraCT #: 2004-002156-34;
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability measures (vital signs, AEs)

  4 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

Org 34517

EXPERIMENTAL

Org 34517 titrated to 900 mg daily for 2 weeks

Drug: SCH 900636

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SCH 900636 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.

Also known as: Org 34517

Org 34517

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Depressive Disorder; Psychotic Disorders; Depression

Interventions

Org 34517

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 16, 2009
• Study Start: September 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: December 31, 2014

Record last verified: 2014-12