The purpose of this study is to compare the safety, effectiveness, and tolerability of two drug therapies for the treatment of acute psychotic depression (PD).

Condition	Treatment or Intervention	Phase
Depression Major Depressive Disorder	Drug: Olanzapine  Drug: Sertraline  Drug: Lithium	Phase III

Further Study Details: 

Expected Total Enrollment:  315

This collaborative four-site randomized controlled trial is the first pharmacological treatment study of major depression associated with delusions to be funded by NIMH in 20 years. The primary aim of the trial is to assess the efficacy of intensive treatment with recently developed medications from the classes of selective serotonin reuptake inhibitors (SSRIs) and atypical antipsychotic medications. Selected medications from each class are used to determine: whether combination therapy is more efficacious than treatment with an antipsychotic medication alone for treating both depressive and delusional symptoms in these patients; and whether geriatric patients respond as well as young adults to pharmacotherapy.

The acute phase of this trial lasts up to 12 weeks to provide patients a maximum time period to achieve a full response. Patients who do not appear to be responding to their research treatment can discontinue the study at any time and receive other forms of treatment (e.g., other medications, Electroconvulsive Therapy (ECT)). Patients who achieve either a partial or full response will be invited to participate in an additional 12 weeks of treatment. This stabilization phase treatment is designed to assess methods for optimizing initial remission and partial remission during acute treatment.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Major Depressive Disorder, single or recurrent, with psychotic features

Exclusion Criteria:

• History of substance abuse or dependence within the last 3 months
• Acute or unstable medical illness

Massachusetts
      University of Massachusetts Medical School, Worcester,  Massachusetts,  01605,  United States; Recruiting
New York
      Cornell University, New York,  New York,  10021,  United States; Recruiting
Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Canada, Ontario
      University of Toronto, Toronto,  Ontario,  M5G 2C4,  Canada; Recruiting

Study chairs or principal investigators

Barnett Meyers, MD,  Principal Investigator,  Cornell University   

Study ID Numbers:  62624-01A2; 62565-01A2,; 62518-01A2,; 62446-01A2
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  March 14, 2003
ClinicalTrials.gov Identifier:  NCT00056472
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08