Effectiveness of Nimodipine Plus Antidepressant Medication in Treating Vascular Depression
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Treatment of Depression Occurring in the Setting of Cerebrovascular Risk -- A Pilot Study|
- Nimodipine-related side effects [ Time Frame: Measured at Week 32 of Phase 2 ] [ Designated as safety issue: Yes ]
- Hamilton Depression Rating Scale [ Time Frame: Measured at Week 32 of Phase 2 ] [ Designated as safety issue: No ]
- Cognitive function, composite score [ Time Frame: Measured at Week 16 and Week 32 of Phase 2 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
In Phase 1, participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive 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.
Other Name: Nimotop
Placebo Comparator: 2
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.
Placebo will be given in doses matching those of nimodipine.
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.
For information on a related study, please follow this link:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781326
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Ellen M. Whyte, MD||University of Pittsburgh|