Status:
TERMINATED
Effectiveness of Nimodipine Plus Antidepressant Medication in Treating Vascular Depression
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Current DSM-IV (Diagnostic and Statistical Manual) diagnosis of major depression
- Score greater than 15 on the 24-item Hamilton Depression Rating Scale (HDRS24)
- Significant cerebrovascular disease risk factors, as defined by the presence of more than three of the following:
- Arterial hypertension, defined by a systolic blood pressure higher than 140 mm Hg or a diastolic blood pressure higher than 90 mm Hg, or by both a self-reported hypertension diagnosis and use of antihypertensive medication
- Diabetes mellitus, defined by a fasting blood glucose level higher than 126 mg/dl or treatment with hypoglycemic agents or insulin in the year before study entry
- Obesity, defined by a current body mass index (BMI) greater than 30
- Hyperlipidemia, defined by either a confirmed prior diagnosis or a current fasting cholesterol level higher than 200 mg/dl
- Current smoker
- Able to swallow oral medication
- Identification of a family member or friend willing and able to participate as a source of corroborating information
- Able to speak English
- A hearing capacity adequate to respond to a raised conversational voice
Exclusion
- Current diagnosis of major depression with psychosis, schizophrenia, bipolar disorder, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, or obsessive compulsive disorder
- Meets DSM-IV criteria for dementia or has a score of 17 or lower on the Mini Mental State Examination
- Met DSM-IV criteria for drug or alcohol dependence within the past 6 months
- Not responsive to therapeutic trials of either escitalopram or duloxetine for the current major depressive episode
- Acute, severe, or unstable medical disorder likely to interfere with treatment, such as untreated thyroid disorder
- History of epilepsy
- Clinically reported stroke within the past year
- First-degree heart block, determined after correcting for age
- Symptomatic hypotension or symptomatic orthostatic hypotension
- History of nontolerance or allergy to both escitalopram and duloxetine therapy, including history of selective serotonin reuptake inhibitor (SSRI)-related syndrome of inappropriate anti-diuretic hormone secretion (SIADH)
- Significant allergy to NIM or other ingredients contained in the study medication
- Taken monoamine oxidase inhibitors (MAOIs) within the 2 weeks prior to the first administration of double-blind study medication
- Requires treatment with amiodarone, protease inhibitors, dalfopristin or quinupristin, valproic acid, triazole antifungal agents (e.g., itraconazole), reserpine, methyldopa, guanethidine, or clonidine during the course of the study
- May require drugs known to interact with NIM during the course of the study
- Refusal to allow the research team to contact participant's primary medical provider
- Planning to become pregnant during the course of the study
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00781326
Start Date
August 1 2008
End Date
February 1 2009
Last Update
September 29 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213