Clinical trial NCT04487730: Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression
Official title: Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Late Life Depression
Psychotherapy
Mechanisms of Action
Positive Valence System
Social Reward
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-07-27
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial. Participants will be randomly assigned to 9-weeks of either "Engage-S" Psychotherapy or "Symptom Review and Psychoeducation" (SRP) Psychotherapy
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Resting State fMRI Connectivity of the Positive Valence System
timeFrame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)
Secondary outcomes:
measure: Change in Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)
measure: Change in Behavioral Activation for Depression Scale (BADS)
timeFrame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Nili Solomonov, PhD
role: PRINCIPAL_INVESTIGATOR
References: