Status:
COMPLETED
Depression Treatment and Risk for Cardiovascular Disease
Lead Sponsor:
East Carolina University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
21-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study was designed to determine the feasibility of a Randomized Controlled Trial (RCT) that involved treating depression among participants with an elevated risk for cardiovascular disease. It is...
Eligibility Criteria
Inclusion
- Males and females age 21-75
- Meet diagnostic criteria for major depressive disorder
- Framingham risk score indicating a greater than negligible 10-year risk (3% or greater) for cardiovascular disease.
- Levels of depressive symptoms of at least moderate level (beck depression inventory II score \> 19 of 63 possible points; or a Hamilton depression rating scale \> 12 of 50 possible points)
Exclusion
- A verbal expression of current, significant, suicidal ideation; a score of \> 15 on the beck scale for suicidal ideation
- Score of \>1 on any single item of the Beck Scale for Suicidal Ideation
- Score of \> 1 on the item assessing suicidal ideation on the beck depression inventory II.
- Psychiatric diagnoses that could potentially interfere with depression treatment (current post traumatic stress disorder, bipolar I disorder, obsessive-compulsive disorder, bulimia or anorexia nervosa, schizophrenia, and panic disorder)
- Current use of an antidepressant medication
- Currently in psychotherapy.
- Current use of a beta blocker, anxiolytic (benzodiazepine), antipsychotic agent
- Diagnosis of CVD.
Key Trial Info
Start Date :
March 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06170255
Start Date
March 6 2014
End Date
October 2 2017
Last Update
December 14 2023
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