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. 2021 Sep 12;2021(9):CD011612. doi: 10.1002/14651858.CD011612.pub3

NCT02037503.

Study name Effect of oral ketamine treatment on suicidal ideation and drug resistant major depression, a clinical and fMRI study
Methods In a double‐blind, placebo‐controlled trial, patients admitted to the emergency department after a suicide attempt will be randomised into two groups: one will be given a daily subanaesthetic dose of oral ketamine, while the second group will receive a daily dose of placebo. Participants will be followed up for 21 days. Some of the participants will also undergo functional MRI scans before and after the first ketamine intake
Allocation: randomised
Endpoint classification: efficacy study
Intervention model: parallel assignment
Masking: double‐blind (participant, investigator, outcomes assessor)
Primary purpose: treatment
Participants Inclusion criteria
Suicidal ideation group:
  • Any person admitted to the emergency room department after a suicide attempt, defined as requiring medical intervention ‐ not just a psychiatrist (surgical or pharmacological treatment but also the need for observation)

  • The need for medical intervention will be defined by the ER ED physician

  • Ages 18‐65


For the depression group
  • Diagnosed with major depression according to DSM VI

  • Ongoing depression (according to DSM criteria) despite treatment with at least two antidepressants in adequate dosages and for longer than three weeks.

  • Ages 18‐65


Exclusion criteria for all groups
  • Psychotic state instate in the examination

  • Diagnosis of schizophrenia/schizoaffective disorder

  • Drug or alcohol abuse as is revealed in by blood/urine tests

  • Patient in which, according to the examiner, there is primary or secondary gain

  • Patient, which, at the time of his admission, is without any pharmacological treatment

Interventions Ketamine versus saline
Outcomes Primary outcome measures: Resolution of suicidal ideation. Time frame: within 3 weeks of enrolment
Starting date January 2014
Contact information  
Notes NCT02037503