- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00226278
Safety Study of ORG 34517 for Major Depression With Psychotic Features
March 28, 2008 updated by: Weill Medical College of Cornell University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
-
New York, New York, United States, 10021
- Weill Cornell Medical College/New York Presbyterian Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: James H Kocsis, MD, Weill Medical College of Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
November 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
September 22, 2005
First Submitted That Met QC Criteria
September 23, 2005
First Posted (Estimate)
September 26, 2005
Study Record Updates
Last Update Posted (Estimate)
March 31, 2008
Last Update Submitted That Met QC Criteria
March 28, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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