Prospective, Double-Blind, Randomized, Placebo-Controlled Dose Finding Study of the Efficacy and Safety of 2 Target Doses of Org 34517 Used as Adjunctive Therapy in Subjects With Psychotic Major Depression (Major Depressive Episode, Severe, With Psychotic Features).

Merck Sharp & Dohme LLC0 sites273 target enrollmentJuly 2004

ConditionsDepression Depressive Disorders Psychotic Disorders

InterventionsOrg 34517 Placebo

DrugsOrg 34517 Placebo

Overview

Phase: Phase 2
Intervention: Org 34517
Conditions: Depression
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 273
Primary Endpoint: PANSS positive symptoms subscale.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with Org 34517. Two doses of Org 34517 will be compared to placebo in this international multicenter study. The duration of this trial is 6 weeks.

Detailed Description

Major depression with psychotic features (psychotic depression) is the most debilitating disorder in the depressive disorders spectrum. It is associated with severe symptoms, prolonged course, poorer response rates, more residual symptoms, more frequent relapses and higher mortality, as compared to major depressive disorder. The markedly abnormal HPA axis functioning in psychotic depression has encouraged research to investigate whether the HPA axis would be a target for pharmacotherapy in depression. The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with GR antagonist Org 34517. Two doses of Org 34517 will be compared to placebo in this international multicenter study. The duration of this trial is 6 weeks.

Registry

clinicaltrials.gov

Start Date

July 2004

End Date

July 2006

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•have provided voluntary written informed consent for trial participation after the scope and nature of the investigation were explained to them, and before starting any trial-related activities (before Screening);
•be able to speak, read, understand, respond to questions, and follow
•instructions in English or their native language;
•have DSM-IV severe depressive episode with psychotic features, as
•diagnosed by the MINI for single or recurrent episodes (296.24 or 296.34);
•have a score on PANSS item "Delusions" AND/OR "Hallucinatory behavior" of at least 4 at Screening and Baseline;
•have a PANSS Positive Scale score of at least 16 at Screening and Baseline;
•have a total score of at least 18 on the HAMD 17-item scale at Screening and Baseline;
•be on a stable dose of "usual treatment", which had to consist of an
•antidepressant, an antipsychotic, a mood stabilizer or any combination of these 3 drug classes;

Exclusion Criteria

•have any other current psychiatric diagnosis (according to the MINI) except MDD, such as organic mental syndromes and disorders, delirium or anxiety disorders;
•have a lifetime psychiatric diagnosis of psychotic disorders (according to the MINI), or a MINI diagnosis of past manic episode;
•be at significant risk of committing suicide, as indicated by a score greater than 9 on the revised InterSePT Scale for Suicidal Thinking (ISST);
•be currently treated with carbamazepine or valproate;
•be currently treated with midazolam;
•be treated with electroconvulsive therapy in the current episode;
•be currently treated with more than one antidepressant;
•be currently treated with more than one antipsychotic;
•be currently treated with more than one mood stabilizer;
•have a "usual treatment" started or discontinued in the 2 weeks before