Skip to main content
MedPathMedPath Home
Clinical Trials/NCT06170255
NCT06170255
Completed
Phase 1

Depression Treatment and Risk for Cardiovascular Disease

East Carolina University0 sites16 target enrollmentMarch 6, 2014
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsDepression

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Depression
Sponsor
East Carolina University
Enrollment
16
Primary Endpoint
Feasibility
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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 expected that treating depression through non-pharmacological means will impact heart rate variability, a proximal measure of CVD risk.

Registry
clinicaltrials.gov
Start Date
March 6, 2014
End Date
October 2, 2017
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthew Whited

Associate Professor of Psychology

East Carolina University

Eligibility Criteria

Inclusion Criteria

  • •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 Criteria

  • •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.

Outcomes

Primary Outcomes

Feasibility

Time Frame: 2 years. Throughout the course of the study (number recruited/screened, number enrolled, number completing the study)

Feasibility of the study including recruitment, enrollment, and retention rates

Secondary Outcomes

  • Heart Rate Variability (HRV)(12 weeks)

Similar Trials

Completed
Not Applicable
Depression Therapy to Improve Cardiovascular Risk in HIVHIVDepression
NCT02309372Indiana University54
Completed
Phase 3
Effectiveness of a Mobile Technology Intervention for the Treatment of DepressionDepressionDiabetesHypertension
NCT02846662University of Sao Paulo General Hospital880
Completed
Not Applicable
Depression Outpatient Cardiology Screening StudyDepressionCoronary Heart Disease
NCT01552889Washington University School of Medicine201
Terminated
Phase 2
The Routine Use of SSRI's at the Initiation of End-stage Renal Disease Treatment (RoSIE)End Stage Renal Disease
NCT02407821University Health Network, Toronto25
Completed
Not Applicable
Screening for Depression in cADiovasCular pAtients at a Tertiary Center in Trinidad.Depression
NCT03863262The University of The West Indies1,203