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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.