Neurocognitive Features of Patients With Treatment-Resistant Depression

March 10, 2020 updated by: Cristina Cusin, MD, Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

13

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligibility for participants includes those ages 18-80 years old who meet criteria for a moderate/severe (as indicated by a score of > 14 on the QIDS-SR) depressive episode (unipolar or bipolar mood disorder), have a history of at least three failed antidepressant trails, and are seeking non-research ketamine treatment through the ketamine clinic at Massachusetts General Hospital (and are deemed appropriate for treatment at the clinic. Participants must also be able to read, understand, and provide written informed consent in English.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Treatment-resistant depression patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline - post at least 2 weeks on a stable dose of intranasal ketamine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

August 9, 2017

Study Completion (Actual)

January 17, 2018

Study Registration Dates

First Submitted

April 18, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P001654

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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