NCT05925322 Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality
| NCT ID | NCT05925322 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2023-09-18 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2023-09-18 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators hypothesized that during the 9-week course of Engage \& Connect treatment there will be an increase in brain functions of the Positive Valence System which in turn will lead to reduction in suicidality.
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.
Contact & Investigator
Nili Solomonov, PhD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT05925322 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05925322 currently recruiting?
Yes, NCT05925322 is actively recruiting participants. Contact the research team at nis2051@med.cornell.edu for enrollment information.
Where is the NCT05925322 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05925322 clinical trial?
NCT05925322 is sponsored by Weill Medical College of Cornell University. The principal investigator is Nili Solomonov, PhD at Weill Medical College of Cornell University. The trial plans to enroll 128 participants.
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