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NCT04239963Completed

Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression

Source: ClinicalTrials.gov · Last updated 30 Oct 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
60 (actual)
First submitted
15 Jan 2020
Start date
17 Aug 2020
Primary completion date
28 Aug 2024
Lead sponsor
Mclean Hospital
Diseases
Depression
NCT number
NCT04239963

What you commit to

  • Study type: Observational
  • Participants enrolled: 60
  • From 17 Aug 2020 to the primary completion date, 28 Aug 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;
  • 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.

Lab values

  • Clinical or laboratory evidence of hypothyroidism, hyperthyroidism, or other thyroid disorder that is not controlled by medication;

Other

  • Substance use assessed by physician as dangerous for ketamine treatment;
  • Untreated glaucoma;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
McLean Hospital
Coordinator of this site? Confirm its status
BelmontUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.