Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Study of ORG 34517 for Major Depression With Psychotic Features

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00226278
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : March 31, 2008
Sponsor:
Information provided by:
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE September 22, 2005
First Posted Date  ICMJE September 26, 2005
Last Update Posted Date March 31, 2008
Study Start Date  ICMJE September 2004
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of ORG 34517 for Major Depression With Psychotic Features
Official Title  ICMJE Prospective, Double Blind, Randomized, Placebo-Controlled Dose Finding Study of the Efficacy and Safety of 2 Target Doses of Org 34517 Used as Adjunct"
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Psychotic Disorders
Intervention  ICMJE Drug: ORG 34517
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September¬†23,¬†2005)
25
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00226278
Other Study ID Numbers  ICMJE 28130
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James H. Kocsis, MD, Weill Cornell Medical College
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James H Kocsis, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date March 2008

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