Adults 50 to 85, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Resting State fMRI Connectivity of the Positive Valence SystemPrimary· 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).
Baseline
Group
Value
95% CI
"Engage & Connect" Psychotherapy
0.18
± 0.03
Symptom Review and Psychoeducation (SRP)
0.18
± 0.02
Week 5
Group
Value
95% CI
"Engage & Connect" Psychotherapy
0.24
± 0.02
Symptom Review and Psychoeducation (SRP)
0.29
± 0.02
Week 9
Group
Value
95% CI
"Engage & Connect" Psychotherapy
0.25
± 0.03
Symptom Review and Psychoeducation (SRP)
0.24
± 0.03
Change in Montgomery Asberg Depression Rating Scale (MADRS)Secondary· 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).
Baseline
Group
Value
95% CI
"Engage & Connect" Psychotherapy
23.66
± 4.62
Symptom Review and Psychoeducation (SRP)
24.81
± 3.39
Mid-treatment (Week 5)
Group
Value
95% CI
"Engage & Connect" Psychotherapy
13.82
± 7.56
Symptom Review and Psychoeducation (SRP)
18.62
± 7.03
Post Treatment (Week 9)
Group
Value
95% CI
"Engage & Connect" Psychotherapy
11.86
± 8.97
Symptom Review and Psychoeducation (SRP)
14.66
± 8.89
Change in Behavioral Activation for Depression Scale (BADS)Secondary· 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).
Baseline
Group
Value
95% CI
"Engage & Connect" Psychotherapy
71.24
± 21.36
Symptom Review and Psychoeducation (SRP)
70.00
± 18.40
Mid-treatment (Week 5)
Group
Value
95% CI
"Engage & Connect" Psychotherapy
95.21
± 28.84
Symptom Review and Psychoeducation (SRP)
88.21
± 20.73
Post Treatment (Week 9)
Group
Value
95% CI
"Engage & Connect" Psychotherapy
98.00
± 30.54
Symptom Review and Psychoeducation (SRP)
93.86
± 25.28
Adverse events — posted to ClinicalTrials.gov
Time frame: 9 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Weill Medical College of Cornell University
Last refreshed: 3 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04487730.