Neurocognitive Features of Patients With Treatment-Resistant Depression

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03134066

Enrollment

Registered

2017-04-28

Start date

2016-09-30

Completion date

2018-01-17

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Resistant Depression

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in pattern separation task results	Baseline - post at least 2 weeks on a stable dose of intranasal ketamine	The pattern separation task is a computer-based behavioral task that captures characteristic of pattern separation processes. Pattern separation is thought to be involved in the process of you finding your car everyday despite being in a different space; this may be dysfunctional in people with depression. The task itself is not an intervention; it is a rapid assessment of putative changes in pattern separation.

Outcome results