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Search / Trial NCT05925322

Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Jun 28, 2023

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

Late Life Depression Psychotherapy Mechanisms Of Action Positive Valence System Social Reward

ClinConnect Summary

This clinical trial is studying how a special therapy called Engage & Connect can help improve brain function in older adults who are experiencing depression and thoughts of suicide. The researchers believe that by participating in this 9-week therapy, patients may see positive changes in their brain activity, which could help reduce feelings of suicidality.

To be eligible for the trial, participants should be between the ages of 50 and 80, have a diagnosis of major depressive disorder, and currently have thoughts of suicide. They should also be stable on their medication or off antidepressants for a while. Participants will not be receiving individual therapy during the study and will undergo brain scans (MRIs) to help researchers understand how the therapy is working. It's important to note that individuals who have severe psychiatric conditions, recent serious medical issues, or certain medical implants that prevent MRI scans cannot participate. Overall, this study aims to provide insights into how therapy can help improve mental health in older adults facing significant challenges.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Ages aged 50-80 \[stratified so that 50% are older than 65\]
  • Endorsement of Suicidal Ideation \[Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 (SCID-5) Suicide Item (Item 9) with a score of 2
  • Major Depressive Disorder as determined by the SCID-5
  • Depression Rating Scale \[Montgomery-Åsberg Depression Rating Scale (MADRS)\] score of 16 or greater.
  • Mini Mental Status Exam (MMSE) equal or greater than a score of 23
  • 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, without individual psychotherapy services during the study period.
  • Capacity to provide consent for research assessment and treatment.
  • Exclusion Criteria:
  • Intent or plan to attempt suicide in the near future.
  • History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia.
  • Use of psychotropic drugs or cholinesterase inhibitors other than use of 0.5 mg or less of lorazepam daily up to seven times per week.
  • Neurological disorders (dementias, amnestic and multidomain Mild Cognitive Impairment, Parkinson's disease, epilepsy, etc.).
  • Acute or severe medical illness in the past 3 months (metastatic cancer, multiple sclerosis, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction, cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease, etc.) that may be the primary cause depressive symptoms, influence brain systems of interest, or impact ability to participate in the study.
  • 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.

About Weill Medical College Of Cornell University

Weill Medical College of Cornell University is a leading academic institution dedicated to advancing medical research and education. As a prominent sponsor of clinical trials, it focuses on innovative healthcare solutions and the development of new therapies across various medical disciplines. The institution is committed to fostering collaborative research efforts that enhance patient care and improve health outcomes. With a robust infrastructure and a team of experienced researchers and clinicians, Weill Cornell aims to translate scientific discoveries into practical applications, ensuring a strong emphasis on ethical standards and regulatory compliance throughout the clinical trial process.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Nili Solomonov, PhD

Principal Investigator

Weill Medical College of Cornell University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported