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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00556140 |
Purpose
The purpose of the study is to assess the safety and effectiveness of the combination of aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with psychotic major depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Psychotic Depression |
Drug: Aripiprazole |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Single Group Assignment |
| Official Title: | The Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants in the Acute Treatment of Psychotic Major Depression: Efficacy and Tolerability |
| Enrollment: | 35 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | January 2008 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Aripiprazole
Aripiprazole is an antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia. You will receive aripiprazole (Abilify) and one of the following SSRI antidepressant medications: sertraline (Zoloft), citalapram (Celexa), or escitalopram (Lexapro). The dose of aripiprazole (Abilify) will be 10 milligrams a day, and the starting doses for the SSRI anti-depressants will be: sertraline (Zoloft) 50 milligrams a day, citalopram (Celexa) 20 milligrams a day, and escitalopram (Lexapro) 10 milligrams a day.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Matthews D John, MD | Massachusetts General Hospital/Harvard Medical School |
More Information
| Study ID Numbers: | 2003-P-000990 |
| Study First Received: | November 8, 2007 |
| Last Updated: | November 8, 2007 |
| ClinicalTrials.gov Identifier: | NCT00556140 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major Affective Disorders, Psychotic Mental Disorders Therapeutic Uses Psychotic Disorders Aripiprazole Antidepressive Agents Schizophrenia and Disorders with Psychotic Features |
Depression Tranquilizing Agents Bipolar Disorder Central Nervous System Depressants Depressive Disorder Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Serotonin Agents Mood Disorders Central Nervous System Agents |