Clinical TrialMajor Depressive Disorder (MDD)KetamineCompleted

Biomarkers of Fast Acting Therapies in Major Depression

Single-group, Phase I study (n=60) assessing IV ketamine infusions (0.5 mg/kg over 40 minutes, up to 4 sessions) in adults with major depression to identify neuroimaging and blood biomarkers of rapid response and relapse.

Target Enrollment
60 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This interventional study enrols 60 adults with major depressive disorder to receive serial subanesthetic IV ketamine infusions (0.5 mg/kg over 40 minutes, up to four doses given two to three times per week) while undergoing multimodal MRI and blood sampling to identify biomarkers of rapid antidepressant response and relapse.

Outcomes include HDRS clinical response, structural and functional MRI metrics, spectroscopy measures of glutamate and related metabolites, inflammatory cytokines, and transcriptome profiling; analyses will examine associations between biomarker changes and symptomatic improvement or relapse.

Study Protocol

Preparation

sessions

Dosing

4 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

IV subanesthetic ketamine infusions (0.5 mg/kg over 40 minutes) up to 4 sessions; imaging and blood biomarker assessments.

Interventions

  • Ketamine0.5 mg/kg
    via IV• 2-3 times/week• 4 doses total

    Diluted in 60 mL saline and given as a slow IV infusion over 40 minutes; additional doses given if no remission up to 4

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age between 18 to 64 years, inclusive
  • Diagnosis: DSM-IV TR criteria for non-psychotic major depression
  • Hamilton Depression Rating Scale-17 item ≥ 18 or Montgomery Asberg Depression Scale ≥ 20
  • A history of at least one previous major depressive episode prior to the current episode
  • Recurrent Depression - in the current episode, have not responded to at least 2 adequate antidepressant trials (using Antidepressant Treatment History Form criteria)
  • Have been continuously depressed for between 6-12 months
  • Receiving approved monoaminergic antidepressant therapy
  • No changes in antidepressant medication(s) in the past one (1) month
  • Voluntary patient receiving ketamine
  • Capacity to provide informed consent
  • Have no contraindications to an adjunctive trial of ketamine infusion
  • Be under the current care of a treating Psychiatrist
  • If outpatient, a responsible driver available for transportation to and from scanning sessions
  • Live locally, within travelling distance to UCLA
  • Be available to participate for a 5-week research follow-up

Exclusion Criteria

  • Exclusion Criteria:
  • Younger than 18 or older than 64
  • Serious and imminent suicidal or homicidal risk (active suicidal ideations with or without a plan, HAM-D score ≥ 3 on item 3)
  • Mental retardation or other developmental disorder
  • Diagnosis of dementia of any type
  • History of current substance abuse or dependence
  • Psychotic reactions to medications, alcohol or illicit substances in the past
  • Current or past history of psychosis, schizophrenia, bipolar disorder, delusional disorder or other psychotic disorder
  • Treatment with medications with NMDA and NMDAR action
  • Contraindication to ketamine
  • Depression related to serious medical illness (i.e., mood disorder due to general medical condition)
  • History of neurological disorder or other physical disorder (i.e. significant head injury) that could affect brain functioning
  • Serious or unstable medical or neurological condition(s) that in the opinion of the treating physician or PI renders ketamine unsafe to administer
  • Any condition that would contraindicate scanning (metal implants, claustrophobia or a breathing or movement disorder)
  • Pregnancy (as confirmed by positive urine pregnancy test) or planning on becoming pregnant
  • Non-English speaking (due to scales administered)
  • Live outside of the Los Angeles area

Study Details

Locations

Geffen School of Medicine, UCLA — Los Angeles, California, United States

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