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CompletedN/A

Neurocognitive Features of Patients With Treatment-Resistant Depression

NCT03134066 · Massachusetts General Hospital

Closed to entry
Status
Not accepting participants
Not applicable
Phase
13
Target enrolment
—
Study sites

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in pattern separation task results

    Measured over Baseline - post at least 2 weeks on a stable dose of intranasal ketamine

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 80 Years
Ages
All
Sex
Not accepted
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

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03134066 on ClinicalTrials.gov →

Last updated in the registry 2020-03-11. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 17 trials from Massachusetts General Hospital →