Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT04239963
• Lead Sponsor: Mclean Hospital

Brief Summary

The overarching goal of the present study is to evaluate the effect of a subanesthetic dose of ketamine 24-hour post-injection on resting state functional connectivity, cognitive control, and reward learning.

Detailed Description

Major Depressive Disorder (MDD) participants with treatment-resistant depression (TRD) will be recruited from McLean's Ketamine clinic. Suitability for Ketamine treatment will be determined as typically done by the service - through evaluation by the clinicians on the staff of the Ketamine Service who perform psychiatric consultations and assessments for Ketamine suitability. Potential subjects will be informed about the study only after they have received a positive consultation at the clinic and have already agreed to receive the treatment.

This study consists of a set of questionnaires, urine drug screen, and electroencephalogram (EEG) recordings.

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-21
• Study First Posted: 2020-01-27
• Study Start: 2020-08-17
• Primary Completion: 2024-08-28
• Study Completion: 2024-08-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials	Baseline	Relative FRP response is the primary outcome measure for the probabilistic reward task (PRT).
Behavioral Performance on the Probabilistic Reward Task (PRT)	Baseline	The Probablilistic Reward Task operationalizes positive reinforcement learning
Event-related negativity (ERN) amplitudes over frontocentral scalp regions in response to correct trials versus incorrect trials.	Baseline	Relative ERN response is the primary outcome measure for the flanker task.
Behavioral Performance on the Flanker Task	Baseline	The Flanker Task is a cognitive task that measures response inhibition to assess the ability to suppress responses that are inappropriate in a particular context.
Rumination	Baseline	Severity of rumination will be assessed using the Rumination Response Scale (RRS). The RRS has a minimum score of 22 and a maximum score of 88. Higher scores indicate higher degrees of ruminative symptoms.

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States