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Clinical Trials/NCT03134066
NCT03134066
Completed
Not Applicable

Neurocognitive Features of Patients With Treatment-Resistant Depression

Massachusetts General Hospital0 sites13 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Treatment Resistant Depression
Sponsor
Massachusetts General Hospital
Enrollment
13
Primary Endpoint
Change in pattern separation task results
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
January 17, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cristina Cusin, MD

Staff Psychiatrist

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in pattern separation task results

Time Frame: 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.

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