Effectiveness of Nimodipine Plus Antidepressant Medication in Treating Vascular Depression

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT00781326

Run by

University of Pittsburgh

People needed

9

Starts

2008-08-01

Expected to finish

2009-02-01

Last updated by the study team

2016-09-29

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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