Clinical TrialBipolar DisorderKetaminePlaceboNot yet recruiting

The Kite Trial: Examining the Effectiveness of Ketamine for Adults with Bipolar Depression

This randomised, double-blind, midazolam-controlled, multicentre trial (n=98) will investigate the efficacy and safety of low-dose subcutaneous ketamine in adults with bipolar depression.

Target Enrollment
98 participants
Study Type
Phase III interventional
Design
Randomized, double Blind

Detailed Description

Parallel-group, randomised, double-blind Phase III RCT comparing twice-weekly subcutaneous ketamine (starting 0.6 mg/kg, titratable up to predefined level 4) versus low-dose subcutaneous midazolam (active placebo) over a 3-week treatment phase (maximum 6 treatments).

Primary outcome is binary remission of depression at Day 19 post-treatment commencement assessed by MADRS; tolerability and safety measured via KSET, BPRS and CADSS-6; an optional 3-week open-label extension allows additional twice-weekly ketamine for participants who continue.

Study Protocol

Preparation

sessions

Dosing

6 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine

experimental

Low-dose subcutaneous ketamine, titratable across predefined levels (0–4).

Interventions

  • Ketamine0.6 - 1.3 mg/kg
    via Other• twice weekly• 6 doses total

    Subcutaneous injection; starting Level 1 = 0.6 mg/kg; titration increments 0.25 mg/kg (L1→L3) and 0.2 mg/kg (L3→L4); minimum tolerated dose 0.5 mg/kg.

Midazolam (active placebo)

active comparator

Low-dose subcutaneous midazolam as active placebo, titratable across same levels during RCT phase.

Interventions

  • Placebo0.025 - 0.05 mg/kg
    via Other• twice weekly• 6 doses total

    Active placebo midazolam (subcutaneous); starting 0.025 mg/kg (L1); titration increments 0.0075 mg/kg (L1→L3) and 0.010 mg/kg (L3→L4).

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Consent and capacity: able to provide written informed consent and fluent in English.
  • Age: 18 years or older at consent.
  • Diagnosis: DSM-5 bipolar I or II disorder, current major depressive episode confirmed by SCID-5.
  • Depression severity: MADRS ≥20.
  • Stable pharmacotherapy: on stable mood-stabilising medication(s) (e.g., lithium, anticonvulsant, atypical antipsychotic) for ≥28 days prior to Day 1 and stable throughout trial unless clinically indicated.
  • Reproductive health: People of childbearing potential must have a negative pregnancy test, not be breastfeeding, use effective contraception during the study, and abstain from gamete donation for specified periods.

Exclusion Criteria

  • Current major depressive episode with mixed features, rapid cycling bipolar disorder, schizoaffective disorder, or schizophrenia.
  • Severe disturbances preventing consent or compliance.
  • Unstable medical conditions or contraindications to ketamine or midazolam per product information.
  • History of ketamine use disorder or any substance use disorder of at least moderate severity in past 6 months.
  • Participation in another clinical trial from Day 1 until first follow-up visit (Day 39).

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment98 participants
  • Timeline
    Start: 2024-06-28
    End: 2027-09-17
  • Compounds
    KetaminePlacebo
  • Topic
    Bipolar Disorder

Locations

Unknown facility — Australia

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