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Medication Treatment for Psychotic Depression
This study is currently recruiting patients.
Sponsored by: | National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
Purpose
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 |
MedlinePlus related topics: Depression; Mental Health
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Acute Pharmacotherapy of Psychotic Depression (STOP-PD)
Expected Total Enrollment: 315
Study start: January 2003;
Expected completion: August 2007
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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