Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression

NCT ID: NCT04239963

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-17
• Study Completion Date: 2024-08-28

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.

Conditions

Major Depressive Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy Controls

Subjects who have no history of clinical depression or other psychological disorder

No interventions assigned to this group

Current MDD

Subjects experiencing a current episode of Major Depressive Disorder.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• All genders, races, and ethnic origins, aged between 18 and 70;
• 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

• All genders, races, and ethnic origins, aged between 18 and 70;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Diego Pizzagalli

Director, Center for Depression, Anxiety and Stress Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diego Pizzagalli, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

Other Identifiers

2019P003371

Identifier Type: -

Identifier Source: org_study_id