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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00781326 |
This study will examine whether combined use of an antidepressant medication and the medication nimodipine reduces risk of depression relapse in patients with vascular depression.
Condition | Intervention | Phase |
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Depression |
Drug: Nimodipine Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Depression Occurring in the Setting of Cerebrovascular Risk -- A Pilot Study |
Estimated Enrollment: | 30 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
In Phase 1, participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive nimodipine.
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Drug: Nimodipine
Nimodipine will be initiated at one, 30-mg tablet three times a day for 1 week, increased to 2 tablets three times a day for 1 week, and then increased to three tablets three times a day for the remaining 30 weeks of the study. Participants who cannot tolerate the maximum dose of 270 mg/day will be maintained at the highest tolerable dose.
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2: Placebo Comparator
In Phase 1, participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive a placebo.
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Drug: Placebo
Placebo will be given in doses matching those of nimodipine.
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Depressed elderly patients often show signs of cerebrovascular disease, commonly known as a stroke. Some scientists theorize that having cerebrovascular disease may affect depression in older adults in one of three ways: by causing depression, by making it more likely that people who have been depressed have a relapse, or by maintaining certain depressive symptoms in those already depressed. The combination of depression and cerebrovascular disease in older adults is referred to as vascular depression and is associated with psychomotor slowing, functional impairment, and cognitive impairment. Additionally, the likelihood of improvement or remission is lower in vascular depression and is more difficult to treat over time.
Nimodipine (NIM) is FDA approved to reduce incidence and severity of problems with blood flow resulting from a particular type of stroke. In addition to improving blood flow in the brain following a stroke, NIM also protects neurons from injury or degeneration and has cognitive and functional benefits. These positive effects of NIM may make it useful for treatment of vascular depression. In a previous study of people with vascular depression, pairing NIM with the antidepressant fluoxetine showed greater improvements in depression treatment outcomes, higher likelihood of full remission, and less incidence of depression recurrence than using fluoxetine alone. This study will examine whether pairing NIM with other antidepressants will reduce recurrence of vascular depression.
Participation in this study will last 56 weeks and will be divided into two phases. Before the first phase, participants will undergo a 2-hour psychiatric evaluation and a 1.5-hour medical examination that will involve a physical examination, blood test, electrocardiogram (EKG), and urine analysis. In the first phase, participants will receive antidepressant medication without NIM. Participants will begin taking escitalopram but may be switched to duloxetine or have lorazepam added to their regimen, depending on individual treatment effectiveness and side effects. The first phase will last between 6 and 24 weeks, ending when the individual participant either responds to medication or experiences 24 weeks of nonresponse. During the first phase, participants will attend weekly study visits, during which researchers will assess medication effectiveness and monitor side effects.
Before the second phase, participants will undergo a half-hour medical examination and a 1.5-hour test of cognitive and physical abilities. At the beginning of the second phase, participants will be randomly assigned to receive either NIM or a placebo in addition to continuing with the antidepressant medication already helping them. Participants will take NIM or the placebo for 8 months, undergoing weekly study visits for the first month and monthly study visits for the last 7 months. During these visits, researchers will monitor the participants' health and reactions to their medications. After 4, 16, and 32 weeks, an EKG test will be performed, and after 16 and 32 weeks, cognitive and physical tests will be performed again. After the 8 months, participants will attend three weekly study visits while their use of medication is lowered and then ended.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Significant cerebrovascular disease risk factors, as defined by the presence of more than three of the following:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Nancy McLaughlin, BSN 412-246-6008 mclaughlinn@upmc.edu | |
Principal Investigator: Ellen M. Whyte, MD | |
Sub-Investigator: Howard Aizenstein, MD, PhD | |
Sub-Investigator: Carmen Andreescu, MD | |
Sub-Investigator: Meryl Butters, PhD | |
Sub-Investigator: Mary Amanda Dew, PhD | |
Sub-Investigator: Alexandre Dombrovski, MD | |
Sub-Investigator: Ariel Gildengers, MD | |
Sub-Investigator: Jordan Karp, MD | |
Sub-Investigator: Mark Miller, MD | |
Sub-Investigator: Charles Reynolds, MD |
Principal Investigator: | Ellen M. Whyte, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Ellen M. Whyte, MD, Assistant Professor of Psychiatry ) |
Study ID Numbers: | K23 MH067710, DATR AK-TNGP1 |
Study First Received: | October 27, 2008 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00781326 |
Health Authority: | United States: Federal Government |
Depressive Disorder, Major Cerebrovascular Disorders Risk Factors Nimodipine |
Calcium, Dietary Depression Mental Disorders Mood Disorders Nimodipine |
Depressive Disorder, Major Depressive Disorder Cerebrovascular Disorders Behavioral Symptoms |
Membrane Transport Modulators Vasodilator Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Calcium Channel Blockers Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |