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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04487730
• Other study ID #: 20-04021860
• Secondary ID: K23MH123864-01
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2024
• Source: Weill Medical College of Cornell University
• Contact: Nili Solomonov, PhD
• Phone: 914-682-9100
• Email: nis2051[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Ages aged 50-85 [stratified so that 50% are older than 65]

2. Diagnosis of unipolar major depressive disorder without psychotic features, determined by the SCID

3. Montgomery-Åsberg Depression Rating Scale (MADRS) score = 20.

4. Mini Mental Status Exam (MMSE) = 1 SD below the mean score for patient's age and education

5. 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.

6. Capacity to provide written consent for research assessment and treatment.

Exclusion Criteria:

1. Intent or plan to attempt suicide in the near future.

2. History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia.

3. Use of psychotropic drugs or cholinesterase inhibitors other than use of = 0.5 mg of lorazepam daily up to seven times per week.

4. 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.

5. 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• "Engage & Connect" Psychotherapy
9-weeks of weekly psychotherapy sessions focused on social reward exposure
• Symptom Review and Psychoeducation (SRP)
9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Resting State fMRI Connectivity of the Positive Valence System	Calculated from fMRI scan. Validation of target engagement.	Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)
Secondary	Change in Montgomery Asberg Depression Rating Scale (MADRS)	10-item Clinician rated measure of depression severity. Scores range from 0 (no depression) to 60 (severe depression).	Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)
Secondary	Change in Behavioral Activation for Depression Scale (BADS)	25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation).	Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)