Neural Mechanisms of Monoaminergic Engagement in Late-life Depression Treatment Response (NEMO)

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The Department of Psychiatry at the University of Pittsburgh is conducting a research study to learn about the changes that occur in the brain when individuals suffer from and then are treated for depression. The NEMO study has two main purposes. The first is to provide medication treatment to individuals ages 60 and older who are currently depressed.

The second part of the study involves completing a series of 4 MRIs, which assess changes in brain function over the course of treatment. This research may help investigators to develop faster and more effective treatment plans in the future, as brain responses that are detected early in treatment may predict how well an individual will respond to antidepressant medication.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Howard Aizenstein; University of Pittsburgh
• Collaborators: National Institute of Mental Health (NIMH); Weill Cornell Institute of Geriatric Psychiatry
• Treatments: Citalopram; Dexetimide; Levomilnacipran; Milnacipran

Criteria

Inclusion Criteria:

• Age greater than or equal to 60 years old

• Current Major Depressive Episode or Current Depressive Disorder Not Otherwise Specified or Dysthymic Disorder

• Montgomery-Asberg Depression Rating Scale (MADRS) greater than or equal to 12

• Modified Mini-Mental State (3MS) score greater than or equal to 84

Exclusion Criteria:

• History of Mania or Psychosis

• Current suicidal ideation that cannot be safely managed within the confines of a clinical trial

• Alcohol or Substance Abuse (current or past 3 months) endorsed via phone screening interview or diagnosed by Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID)

• Dementia of any etiology endorsed via phone screening interview or diagnosed by SCID

• Medical conditions with known significant effects on mood (e.g., stroke, current hypothyroid state) as well as unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cardiovascular risk factors that are not under medical management Unwilling or clinically determined to be unable to taper from high doses of benzodiazepines (equivalent to > 2 mg lorazepam/day) or other anti-depressant/anti-anxiety medications at time of screening. However, for participants who are prescribed low dose psychotropics for pain, sleep disturbances, and/or medical conditions (e.g. amitriptyline for peripheral neuropathy, low dose trazodone as a sleep aid), these will be allowed in most circumstances. We will include participants on certain dosages of the most commonly prescribed antidepressants (for medical reasons) as follows: amitriptyline up to 50 mg/d, doxepin up to 50 mg/d, trazodone up to 100 mg/d, and imipramine up to 50 mg/d. Participants will also be able to continue taking buspirone, an antianxiety medication. As per the examples above, the PI will decide if the participants are eligible for the study and if they may continue the current medication. Justification regarding all decisions will be documented in the research record.

• Inability to complete required assessments including brain MRI and blood draw

• Hearing/vision impairment precluding neuropsychological testing

• Difficulty conversing in English

• Clinical contraindication to use of escitalopram or levomilnacipran or history of treatment resistance to escitalopram or levomilnacipran

• Unable or unwilling to provide a secondary/emergency contact person

• History of stroke with residual symptoms, current epilepsy, or current post-concussive symptoms

• Clinically relevant hyponatremia (below 130 mEq/L)

• Significant renal impairment