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Sponsored by: |
Weill Medical College of Cornell University |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00226278 |
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.
Condition | Intervention | Phase |
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Major Depressive Disorder Psychotic Disorders |
Drug: ORG 34517 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Double Blind, Randomized, Placebo-Controlled Dose Finding Study of the Efficacy and Safety of 2 Target Doses of Org 34517 Used as Adjunct" |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Weill Cornell Medical College/New York Presbyterian Hospital | |
New York, New York, United States, 10021 |
Principal Investigator: | James H Kocsis, MD | Weill Cornell Medical College |
Responsible Party: | Weill Cornell Medical College ( James H. Kocsis, MD ) |
Study ID Numbers: | 28130 |
Study First Received: | September 22, 2005 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00226278 |
Health Authority: | United States: Food and Drug Administration |
Schizophrenia Signs and Symptoms Depression Mental Disorders Mood Disorders |
Psychotic Disorders Depressive Disorder, Major Depressive Disorder Schizophrenia and Disorders with Psychotic Features Behavioral Symptoms |
Pathologic Processes Disease |