Clinical TrialTreatment-Resistant Depression (TRD)KetamineCompleted

Resistant Depression – Ketamine Infusion Trial Evaluation

This Phase I, dose-escalation safety study (n=24) evaluated repeated 0.5 mg/kg IV ketamine infusions in adults with treatment-resistant depression.

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

Detailed Description

Open-label, single-centre Phase I dose-escalation study (ReD-KITE) administering 0.5 mg/kg ketamine IV over 40 minutes: stage 1 once weekly for three weeks, stage 2 twice weekly for three weeks; total study duration including follow-up ~3 months.

Primary outcome assessed safety and tolerability across acute timepoints and follow-up; mood outcomes were collected repeatedly up to day 98. Results published (PubMed PMID:24699062).

Study Protocol

Preparation

sessions

Dosing

6 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine IV

experimental

Repeated intravenous ketamine infusions with dose-escalation stages (0.5 mg/kg infusions).

Interventions

  • Ketamine0.5 mg/kg
    via IV• per infusion

    0.5 mg/kg IV over 40 minutes; stage 1 once weekly ×3; stage 2 twice weekly ×3.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Current inclusion criteria as of 25/10/2012: 1. Suffering from Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) major depression (uni-polar or bi-polar)
  • 2. Current or past history of lack of response to two adequate antidepressant trials operationally defined using the Antidepressant Treatment History Form (ATHF)
  • 3. Medically fit to receive ketamine in opinion of Consultant Anaesthetist
  • 4. Aged over 18 years, either sex
  • 5. Willing and competent to give informed consent for participation in the study
  • 6. Good understanding of English
  • 7. If a daypatient, must be accompanied until 6 am on the day after each treatment by a competent adult
  • 8. Participant has previously been assessed by a psychiatrist.
  • 9. Able (in the Investigator's opinion) and willing to comply with all study requirements.
  • 10. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study and any clinically significant changes.

Exclusion Criteria

  • Current exclusion criteria as of 25/10/2012: 1. Schizophrenia or schizoaffective disorder
  • 2. Dementia or diagnosis of mild cognitive impairment
  • 3. Closed angle glaucoma
  • 4. Individuals with a poor understanding of English
  • 5. Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
  • 6. Participant who is terminally ill
  • 7. Known hypersensitivity to the drug Ketamine
  • 8. Uncontrolled hypertension
  • 9. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Study Details

Locations

Oxford Health NHS foundation trust — Oxford, United Kingdom

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