White Plains, New York 10605

  • Major Depressive Disorder

Purpose:

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).


Study summary:

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).


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.


NCT ID:

NCT03688139


Primary Contact:

Principal Investigator
Jennifer N Bress, PhD
Weill Medical College of Cornell University

Jennifer N Bress, PhD
Phone: 914-997-8683
Email: jeb2061@med.cornell.edu


Backup Contact:

N/A


Location Contact:

White Plains, New York 10605
United States

Jennifer N Bress, PhD
Phone: 914-997-8683
Email: jeb2061@med.cornell.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 28, 2022

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