Clinical trial NCT03688139: Reward Function and Therapy for Late-Life Depression
Official title: Positive Valence System Function and Reward Exposure Therapy for Late-Life Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depression
major depressive disorder
mental health
mood disorder
geriatric
late-life
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-09-28
Enrollment: 65
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: Late-life depression is prevalent and devastating, and response rates to even the most effective treatments are low. Outcomes may be improved by developing targeted interventions such as Engage - a new, easily disseminated, neurobiologically informed psychotherapy for late-life depression designed to restore impaired function of neural reward systems. This study will use event-related potentials and a panel of other reward system measures to assess target engagement in depressed older adults receiving Engage therapy, with a comparison group of depressed peers receiving supportive therapy. Participants will be randomly assigned to either Engage or supportive therapy and will complete research assessments at baseline and weeks 3, 6, and 9 (end of treatment).

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.

Primary outcomes:
measure: Change in Late Positive Potential to Rewarding Stimuli
timeFrame: Change from baseline to week 9
measure: Change in the Reward Positivity
timeFrame: Change from baseline to week 9
measure: Change in P1
timeFrame: Change from baseline to week 9
measure: Change in Behavioral Activation
timeFrame: Change from baseline to week 9
Secondary outcomes:
measure: Change in Anhedonia
timeFrame: Change from baseline to week 9
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jennifer N Bress, PhD
role: PRINCIPAL_INVESTIGATOR
References: