Clinical TrialTreatment-Resistant Depression (TRD)KetamineRecruiting

An open-label feasibility study of ketamine-assisted therapy in adults with treatment-resistant depression

Open-label, non-randomised feasibility study (n=30) of three weekly IM ketamine sessions (with optional small supplemental dose) combined with preparatory and integration psychotherapy for adults with treatment-resistant depression.

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Target Enrollment
30 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

This single-group feasibility study evaluates ketamine-assisted psychotherapy in adults with treatment-resistant depression across three consecutive weekly intramuscular dosing visits paired with structured preparation and integration psychotherapy sessions.

Dosing is weight-stratified with typical per-session dosing up to 0.75 mg/kg and an optional 20-40 mg supplemental injection 12 minutes after the initial dose; psychotherapy sessions are two hours for preparation and two hours for each integration visit. Outcomes include change in MADRS with follow-ups 1 day after each administration, 1 week, 1 month, 3 months and 6 months after final administration.

Study Protocol

Preparation

1 sessions
120 min each

Dosing

3 sessions

Integration

3 sessions
120 min each

Therapeutic Protocol

support

Study Arms & Interventions

Ketamine-assisted therapy

experimental

Three weekly intramuscular ketamine dosing sessions combined with structured psychotherapy (preparation and integration sessions).

Interventions

  • Ketamine0.5 - 0.75 mg/kg
    via IM• weekly• 3 doses total

    Weight-stratified dosing: sessions 1–3 typically 0.5–0.75 mg/kg for 50–100 kg (session1 initial 0.5 mg/kg); participants >100 kg receive lower initial doses (0.3–0.5 mg/kg). Optional supplemental dose 20–40 mg given ~12 minutes after first injection per protocol; see protocol for full schedule.

Participants

Ages
18 – 69
Sexes
Male & Female

Inclusion Criteria

  • Adult patients who meet DSM-5 criteria for Major Depressive Disorder or Bipolar Disorder and:
  • 1) Willing and able to give informed consent for participation in the study
  • 2) Male or female, aged 18 years or above and less than age 70
  • 3) If Bipolar Disorder, must be on a mood-stabilising medication for the duration of the study
  • 4) Current depressive episode for at least three months
  • 5) MADRS ≥ 20
  • 6) Inadequate response to at least two antidepressant treatments, one of which can include the current episode
  • 7) Must be stable on any psychotropic medication for at least four weeks prior to the study day.

Exclusion Criteria

  • Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
  • Significant renal or hepatic impairment
  • Cardiovascular conditions including severe cardiovascular disease, heart failure, severe or poorly controlled hypertension, recent myocardial infarction, history of stroke, cerebral trauma, or intracerebral mass or haemorrhage
  • Abnormal heart rate or blood pressure checked at screening
  • Participants who have participated in another research trial involving an investigational product in the past 12 weeks
  • History of significant psychotic episode(s)
  • Any unstable medical or neurologic condition
  • Planned major changes to psychotropic medication
  • Imminent risk of suicide as determined by the CSSRS and MADRS/clinical interview
  • Planned or probable use of ECT
  • Active substance use disorder in the previous 6 months
  • Regular use of any medication deemed to be contraindicating as judged by the attending study physicians
  • Inability to speak or read English
  • Any history of abuse of ketamine or phencyclidine
  • Contraindication to the use of ketamine according to manufacturer guidelines including hypersensitivity to the drug or its components
  • Planned use of ketamine, for example, for pain control
  • Unable to fast for four hours prior to administration of ketamine
  • Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial
  • Body-weight <50 kg or >120 kg
  • Current use of the following medications: memantine / amantadine / rimantadine / dextromethorphan / procyclidine / lamotrigine.

Study Protocol, Arms & Participants

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Study Details

Locations

Unknown facility — Australia

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