Neurocognitive Features of Patients With Treatment-Resistant Depression

Mass General Brigham

Status: Completed

Conditions: Treatment Resistant Depression

Study type: Observational

Funder types: Other

Identifiers

NCT03134066

2016P001654

Details and patient eligibility

About

There is an urgent need for novel and effective interventions for treatment-resistant depression (TRD). In previous studies, ketamine has been shown to rapidly reduce depressive symptoms; however, the exact mechanisms of action of ketamine remain unknown. There are some preliminary findings to suggest that ketamine may exert its antidepressant effects through promotion of neurogenesis in the dentate gyrus. The aim of this study is to help delineate the neurocognitive effects of ketamine exposure using a behavioral task (specifically, a pattern separation task) and a battery of other well-established cognitive measures.

This is an assessment-only study, as we will be recruiting subjects to complete an assessment battery at two time points, before and after receiving ongoing ketamine administrations for at least four weeks.

Enrollment: 13 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. be 18-80 years old
2. be able to read, understand, and provide written informed consent in English,
3. meet criteria for a current moderate/severe (> 14 on QIDS-SR) depressive episode (unipolar or bipolar mood disorder),
4. have a history of > 3 failed antidepressant trials, and be
5. be seeking ketamine ongoing treatment through the ketamine clinic at Massachusetts General Hospital and be deemed appropriate for the clinic.

Exclusion criteria

1. Subjects who will not provide consent to neuropsychological testing
2. Subjects who are not deemed appropriate for the ketamine clinic will not be enrolled

Trial design

13 participants in 1 patient group

Treatment-resistant depression patients

Description:

Subjects with TRD who have been deemed appropriate for (and have decided to receive) clinical, non-research ketamine treatment at the ketamine clinic at Massachusetts General Hospital. As this is an assessment-only observational study, no treatment assignment or randomization procedures will be used.