NCT04487730Completed
Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression
Source: ClinicalTrials.gov · Last updated 3 Jun 2025
Brief summary (registry, in English)
Abnormalities in the Positive Valence System (PVS) are associated with depressive symptoms and reduced behavioral activation in mid- and late-life. This study will investigate the engagement of the PVS during exposure to social rewards, part of a novel streamlined psychotherapy for mid- and late-life depression. Use of computational modeling will enable identification of neuroimaging and behavioral profiles associated with greater treatment response, and may guide future personalization of psychotherapy.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 23 Jul 2020
- Start date
- 15 Oct 2020
- Primary completion date
- 13 Aug 2024
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Depression
- NCT number
- NCT04487730
What you commit to
- Study type: Interventional
- Participants enrolled: 64
- From 15 Oct 2020 to the primary completion date, 13 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of lorazepam daily up to seven times per week.
Other illness
- History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia.
- Neurological disorders (dementias, history of stroke, multiple sclerosis, Parkinson's disease, epilepsy, etc.); cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease; metastatic cancer; or debilitated states or less common medical illnesses that may either influence brain systems of interest or ability to participate in the study. Dr. Alexopoulos or another research psychiatrist will review any medical illnesses that does not appear in the list above and determine whether it interferes with the study of positive valence system functions in depression.
- Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, insulin pump, cochlear implant, any other metallic biomedical implant contraindicating to MRI, and claustrophobia.
Other
- Intent or plan to attempt suicide in the near future.
Who the study is looking for
- Ages aged 50-85 \[stratified so that 50% are older than 65\]
- Diagnosis of unipolar major depressive disorder without psychotic features, determined by the SCID
- Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 20.
- Mini Mental Status Exam (MMSE) ≤ 1 SD below the mean score for patient's age and education
- Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 10 weeks.
- Capacity to provide written consent for research assessment and treatment.
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.