Safety Study of ORG 34517 for Major Depression With Psychotic Features

This study has been completed.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00226278
First received: September 22, 2005
Last updated: March 28, 2008
Last verified: March 2008

September 22, 2005
March 28, 2008
September 2004
November 2005   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00226278 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of ORG 34517 for Major Depression With Psychotic Features
Prospective, Double Blind, Randomized, Placebo-Controlled Dose Finding Study of the Efficacy and Safety of 2 Target Doses of Org 34517 Used as Adjunct"

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Major Depressive Disorder
  • Psychotic Disorders
Drug: ORG 34517
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
November 2005
November 2005   (final data collection date for primary outcome measure)

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
  • have a usual treatment dose change within the week prior to randomization
  • have any clinically unstable or uncontrollable renal, hepatic, respiratory, haematological, cardiovascular or cerebrovascular disease that would put the patient at risk of safety or bias assessment efficacy
  • have known hypersensitivity reactions to glucocorticoid antagonists
  • have any clinically significant abnormal laboratory data
  • have any untreated or uncompensated clinically significant endocrine disorder
  • have a diagnosis or alcohol and/or drug dependence
  • have a confirmed positive result on the drug screening test for any illicit drug except cannabis
  • are using hormone replacement therapy at Screening
  • require concomitant treatment with corticosteroids
  • are subjects diagnosed with Cushing disease
  • are women of childbearing potential without adequate contraception
  • are women with a positive pregnancy test at screening or baseline or are breastfeeding mothers
  • are male subjects with current diagnosis of prostrate hypertrophia or past history of symptoms of prostrate hypertrophia.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00226278
28130
Not Provided
James H. Kocsis, MD, Weill Cornell Medical College
Weill Medical College of Cornell University
Not Provided
Principal Investigator: James H Kocsis, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP