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Sponsors and Collaborators: |
Rush University Medical Center AstraZeneca |
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Information provided by: | Rush University Medical Center |
ClinicalTrials.gov Identifier: | NCT00174603 |
The purpose of this study is to examine the mood stabilizing and antipsychotic properties of quetiapine in the treatment of depression by comparing subjects who were randomly assigned to either quetiapine monotherapy, quetiapine and citalopram; or haloperidol and citalopram. We hypothesize that quetiapine monotherapy would have similar effects to the combination of a first generation antipsychotic plus an antidepressant for the treatment of a major depressive episode with psychosis.
Condition | Intervention | Phase |
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Major Depression With Psychotic Features |
Drug: quetiapine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Major Depressive Disorder With Psychotic Features With Quetiapine Monotherapy; Quetiapine and Citalopram; or Haloperidol and Citalopram |
Estimated Enrollment: | 60 |
Study Start Date: | August 2005 |
Study Completion Date: | January 2007 |
Thus, current practice for treating psychotic depression is to combine an antidepressant with an antipsychotic. However, there are limitations to this approach. The rate of response is still lower than in other forms of major depression (Janicak et al., 2001). The rate of noncompliance is higher in this group; and the incidence of adverse effects related to the antipsychotic is increased (Janicak et al., 2001). As a result, studies have examined alternative treatments. The present study proposes to examine quetiapine's antipsychotic and mood stabilizing properties for the treatment of a major depressive disorder with psychotic features Subjects will be randomized to either quetipine monotherapy, quetiapine and citalopram; or haloperidol and citalopram.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Rush University Medical Center | |
Chicago,, Illinois, United States, 60612 |
Principal Investigator: | Philip G Janicak, MD | Rush University Medical Center |
Study ID Numbers: | IRUSQUET305 |
Study First Received: | September 9, 2005 |
Last Updated: | December 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00174603 |
Health Authority: | United States: Food and Drug Administration |
depression psychosis |
Depression Depressive Disorder, Major Depressive Disorder Citalopram Behavioral Symptoms Schizophrenia Haloperidol |
Quetiapine Haloperidol decanoate Mental Disorders Mood Disorders Psychotic Disorders Dexetimide Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |