Status:
COMPLETED
Intravenous Ketamine Plus Neurocognitive Training for Depression
Lead Sponsor:
Rebecca Price
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
This study has two aims: 1) to characterize the effects of intravenous ketamine on neurocognitive markers in depressed patients; 2) to test the efficacy of a synergistic intervention for depression co...
Detailed Description
This study measures clinical and mechanistic outcome trajectories following ketamine (with or without adjunctive neurocognitive training) measured over an acute (30-day) period; and subsequently (for ...
Eligibility Criteria
Inclusion
- Participants will:
- be between the ages of 18 and 60 years,
- have not responded to one or more adequate trials of FDA-approved antidepressants within the current depressive episode, determined by Antidepressant Treatment History Form
- score ≥ 25 on the Montgomery Asberg Depression Rating Scale (MADRS)
- score \>1SD above the normative mean on the Cognitive Triad Inventory "self" subscale \*OR\* \<1SD below the normative mean on the Rosenberg self-esteem scale
- possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
- agree to sign a release of information (ROI), identifying another individual \[friend, family member, etc.\] as a contact person while the patient is enrolled in the study.
Exclusion
- Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., substance use disorder); or lifetime recreational ketamine or PCP use
- Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks
- Failure to meet standard MRI inclusion criteria: those who have cardiac pacemakers, neural pacemakers, cochlear implants, metal braces, or other non-MRI-compatible metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results.
- Current pregnancy or breastfeeding, or failure to engage in an effective birth control strategy throughout the duration of the study
- Acute suicidality or other psychiatric crises requiring treatment escalation.
- Changes made to treatment regimen within 4 weeks of baseline assessment
- Reading level \<6th grade
- For study entry, patients must be reasonable medical candidates for ketamine infusion, as determined by a board-certified physician co-investigator during study screening. Serious, unstable medical illnesses including respiratory \[obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics\], cardiovascular \[including ischemic heart disease and uncontrolled hypertension\], and neurologic \[including history of severe head injury\] will be exclusions.
- Clinically significant abnormal findings of laboratory parameters \[including urine toxicology screen for drugs of abuse\], physical examination, or ECG.
- Uncontrolled or poorly controlled hypertension, as determined by a board-certified physician co-investigator's review of vitals collected during screening and any other relevant medical history/records.
- Patients with one or more seizures without a clear and resolved etiology.
- Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening. Birth control is not an exclusion.
- Past intolerance or hypersensitivity to ketamine or midazolam.
- Patients taking medications with known activity at the NMDA or AMPA glutamate receptor \[e.g., riluzole, amantadine, lamotrigine, memantine, topiramate, dextromethorphan, D-cycloserine\], or the muopioid receptor.
- Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide
- Patients who have received ECT in the past 6 months prior to Screening.
- Patients currently receiving treatment with vagus nerve stimulation (VNS) or repetitive transcranial stimulation (rTMS).
- Patients taking benzodiazepines (within 8 hours of infusion) or GABA agonists
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2022
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT03237286
Start Date
December 1 2017
End Date
October 18 2022
Last Update
March 19 2024
Active Locations (1)
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1
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213