- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06170255
Depression Treatment and Risk for Cardiovascular Disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Depression treatment
Participants receive behavioral therapy for depression
|
Behavioral activation involves an exploration of the patient's individualized values and follows with goal setting to improve depression symptoms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years. Throughout the course of the study (number recruited/screened, number enrolled, number completing the study)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate Variability (HRV)
Time Frame: 12 weeks
|
Change in HRV from enrollment to post-treatment
|
12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5K23HL109620 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Behavioral Activation (BA)
-
Providence VA Medical CenterCompletedDepression | DiabetesUnited States
-
National Center for Telehealth and TechnologyVA Office of Research and DevelopmentCompleted
-
Thomas Jefferson UniversityJohns Hopkins University; University of Pennsylvania; National Institute on Aging... and other collaboratorsCompletedMild Cognitive Impairment (MCI)United States
-
Memorial Sloan Kettering Cancer CenterRecruitingSurvivorshipUnited States
-
Research Foundation for Mental Hygiene, Inc.Completed
-
Dartmouth-Hitchcock Medical CenterNational Cancer Institute (NCI)Completed
-
Indiana UniversityNot yet recruitingDepression | Anxiety
-
United States Naval Medical Center, San DiegoNaval Health Research CenterCompletedMajor Depressive Disorder | Posttraumatic Stress DisorderUnited States
-
Hennepin Healthcare Research InstituteCompleted
-
Wills EyeTemple University; Thomas Jefferson UniversityCompletedGlaucoma | Diabetes Mellitus, Type 2 | Diabetic RetinopathyUnited States