Prospective, Double Blind, Randomized, Placebo-Controlled Dose Finding Study of the Efficacy and Safety of 2 Target Doses of Org 34517 Used as Adjunct"

Weill Medical College of Cornell University1 site in 1 country25 target enrollmentSeptember 2004

ConditionsMajor Depressive Disorder Psychotic Disorders

DrugsORG 34517

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: Weill Medical College of Cornell University
Enrollment: 25
Locations: 1
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Patients suffering from Major Depressive Disorder with Psychotic features who have received no changes in their medications in the previous two weeks will receive "usual" treatment of antidepressants, antipsychotics and/or mood stabilizers and adjunct therapy using ORG34517. The patient will be hospitalized for up to two weeks to monitor their medications and progress and will return to the site for periodic assessments.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

November 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Weill Medical College of Cornell University

Eligibility Criteria

Inclusion Criteria

•provide voluntary written informed consent for trial participation after the scope and nature of the investigation have been explained to them, and before starting any trial related activities
•be able to speak, read, understand, respond to questions and follow instructions in English
•have a DSM-IV severe depressive episode with psychotic features, as diagnosed by the MINI for single or recurrent episodes
•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 teh HAMD 17 item scale at Screening and Baseline
•be on a stable dose of usual treatment which has to consist of an anti-depressant, an antipsychotic, a mood stabilizer or any combination of these three drug classes
•be 18 up to and including 70 years of age at Screening
•must be willing to be hospitalized for at least 11 days from Screening onwards.

Exclusion Criteria

•have any other psychiatric diagnosis except MDD
•have a lifetime psychiatric diagnosis of Bipolar Disorder I, schizophrenia or schizoaffective disorders
•are at significant risk of committing suicide
•are currently treated with carbamazepine or valproate
•are currently treated with midazolam
•have been treated with electroconvulsive therapy in the current episode
•are currently treated with more than one antidepressant
•are currently treated with more than one antipsychotic
•are currently treated with more than one mood stabilizer
•have usual treatment started or discontinued in the two weeks before randomization