N/A
N=65
Reward Function and Therapy for Late-Life Depression
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03688139 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Change in Late Positive Potential to Rewarding Stimuli — 0.80; 0.07 microvolts — p=.08
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Engage Therapy (Behavioral); Supportive Therapy (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Late Positive Potential to Rewarding Stimuli |
0.80; 0.07 | .08 |
| PRIMARY Change in the Reward Positivity |
-0.46; -0.60 | .69 |
| PRIMARY Change in P1 |
-0.24; 0.43 | .69 |
| PRIMARY Change in Behavioral Activation |
12.88; 18.93 | .39 |
| SECONDARY Change in Anhedonia |
-3.37; -2.07 | .58 |
Summary
The goal of this study is to learn about changes in the brain that occur during Engage, a psychotherapy for depression in older adults, and how they may differ from changes that occur during supportive therapy. Older adults with depression will receive 9 weeks of either Engage or supportive therapy and will complete research assessments before the therapy begins and at weeks 3, 6, and 9 of treatment. Research assessments will include questionnaires, computer tasks, and recordings of electrical brain activity (also called electroencephalography or EEG).
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to 60 years.
- Diagnosis of unipolar major depressive disorder without psychotic features, determined by Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID).
- Montgomery-Asberg Depression Rating Scale (MADRS) score greater than or equal to 20.
- Mini Mental State Exam (MMSE) score greater than or equal to 24.
- Off antidepressants or on a stable dose of an antidepressant for 12 weeks and no intent to change the dose in the next 10 weeks.
- Capacity to provide written consent for both research assessment and treatment.
Exclusion Criteria
- Intent or plan to attempt suicide in the near future.
- Presence of current psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia.
- History of past psychiatric diagnoses other than major depressive disorder without psychotic features or anxiety disorders (separation anxiety disorder, specific phobia, social phobia, panic disorder, agoraphobia, or generalized anxiety disorder).
- Use of psychotropic drugs or cholinesterase inhibitors other than use of less than or equal to 0.5 mg of lorazepam daily up to five 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 neural systems of interest or ability to participate in the study.
Data sourced from ClinicalTrials.gov (NCT03688139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.