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Completed

NCT Number: NCT04487730

Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 of lorazepam daily up to seven times per week.
  • 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.

Treatment and study plan

"Engage & Connect" Psychotherapy

Behavioral

9-weeks of weekly psychotherapy sessions focused on social reward exposure

Symptom Review and Psychoeducation (SRP)

Behavioral

9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging

Primary outcomes

  1. Change in Resting State fMRI Connectivity of the Positive Valence System

    Time frame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)

    Calculated from fMRI scan. Validation of target engagement (resting state functional connectivity (rsFC) within the right hemisphere orbital prefrontal cortex (OFC), specifically between the lateral and medial regions of the OFC).

Secondary outcomes

  1. Change in Montgomery Asberg Depression Rating Scale (MADRS)

    Time frame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)

    10-item Clinician rated measure of depression severity. Scores range from 0 (no depression) to 60 (severe depression).

  2. Change in Behavioral Activation for Depression Scale (BADS)

    Time frame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)

    25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation).

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2020
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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