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Neurocognitive Features of Patients With Treatment-Resistant Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03134066
Recruitment Status : Completed
First Posted : April 28, 2017
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date April 18, 2017
First Posted Date April 28, 2017
Last Update Posted Date March 11, 2020
Actual Study Start Date September 2016
Actual Primary Completion Date August 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 27, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neurocognitive Features of Patients With Treatment-Resistant Depression
Official Title Not Provided
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Treatment Resistant Depression
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 10, 2020)
13
Original Estimated Enrollment
 (submitted: April 27, 2017)
30
Actual Study Completion Date January 17, 2018
Actual Primary Completion Date August 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03134066
Other Study ID Numbers 2016P001654
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Cristina Cusin, MD, Massachusetts General Hospital
Original Responsible Party Same as current
Current Study Sponsor Massachusetts General Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Massachusetts General Hospital
Verification Date March 2020