Neurocognitive Features of Patients With Treatment-Resistant Depression

Treatment Resistant Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134066
• Other study ID #: 2016P001654
• Status: Completed
• Start date: September 2016
• Est. completion date: January 17, 2018

Study information

• Verified date: March 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 17, 2018
• Est. primary completion date: August 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pattern separation task results	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