Effectiveness of Nimodipine Plus Antidepressant Medication in Treating Vascular Depression

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Antidepressive Agents; Nimodipine

Criteria

Inclusion Criteria:

• 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:

1. 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

2. 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

3. Obesity, defined by a current body mass index (BMI) greater than 30

4. Hyperlipidemia, defined by either a confirmed prior diagnosis or a current fasting cholesterol level higher than 200 mg/dl

5. 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 Criteria:

• 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