Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression

  • STATUS
    Recruiting
  • End date
    Aug 14, 2023
  • participants needed
    60
  • sponsor
    Mclean Hospital
Updated on 14 August 2021
ketamine
depression
drugs of abuse
psychosis
psychiatric disorder
antidepressants
scid
structured clinical interview
hdrs

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.

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.

Details
Condition major depressive disorders, major depressive disorder, Major depression, Endogenous depression
Clinical Study IdentifierNCT04239963
SponsorMclean Hospital
Last Modified on14 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All genders, races, and ethnic origins, aged between 18 and 64
DSM-5 diagnostic criteria for MDD (diagnosed with the use of the Structured Clinical Interview for DSM-5 (SCID-5))
A score of 32 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30)
Capable of providing written informed consent, and fluent in English
Right-handed
Treatment Resistant (as assessed using the MGH Antidepressant Response Questionnaire)
Have already decided to receive ketamine treatment as part of their standard clinical care
Inclusion Criteria (Control Subjects)
All genders, races, and ethnic origins, aged between 18 and 64
Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (SCID-I/NP)
A baseline Quick Inventory of Depressive Symptomatology (QIDS) score 5
A baseline Hamilton Depression Rating Scale (HDRS) score 7
Capable of providing written informed consent, and fluent in English
Right-handed
No first-degree relative with mood or psychotic disorder

Exclusion Criteria

Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
History of seizure disorder
History or current diagnosis of any of the following DSM-5 psychiatric illnesses: schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, substance abuse disorder
Clinical or laboratory evidence of hypothyroidism, hyperthyroidism, or other thyroid disorder that is not controlled by medication
Substance use assessed by physician as dangerous for ketamine treatment
Untreated glaucoma
Complex post-traumatic stress disorder (PTSD) with dissociation
Patients with a lifetime history of electroconvulsive therapy (ECT)
Participants with a lifetime history of ketamine use
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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