Clinical TrialDepressive DisordersKetamineNot yet recruiting

Feasibility of oral ketamine for bipolar depression: a 20-week open-label study

This open-label Phase II trial (n=30) evaluated the safety and efficacy of ketamine for bipolar disorder bipolar depression using 70mg/70kg ketamine.

Target Enrollment
30 participants
Study Type
Phase II interventional
Design
Randomized

Detailed Description

Bipolar depression is often persistent and disabling with limited treatment options.
Ketamine is a pain-relief and anaesthetic medication that has emerged as a new treatment for standard or non-bipolar depression. Some early studies suggest that ketamine may also help bipolar depression but these were short-term and involved ketamine injections. This study seeks to see if it is feasible to treat bipolar depression with a course of oral ketamine. We also seek to determine any mood improvements and the safety and tolerability of the ketamine course.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Ketamine

Participants

Inclusion Criteria

  • Age 18-65 years.
  • Diagnosis of Bipolar I or II Disorder according to DSM-5 (American Psychiatric Association, 2013) criteria.
  • Current Major Depressive Episode according to DSM-5 (American Psychiatric Association, 2013) criteria.
  • On stable psychiatric medications for at least 4 weeks prior to screening. Bipolar 1 disorder patients required to be on mood stabilising treatment (recommended doses of an antipsychotic medication, lithium carbonate, or sodium valproate). Maintenance treatment with lamotrigine only is not sufficient (because it typically has limited efficacy for preventing mood elevation) unless individual circumstances suggest there has been an extended period of stability on lamotrigine without other mood stabilisers.

Exclusion Criteria

  • History of current or recent substance disorder within the past 6 months (excluding nicotine use disorder and mild cannabis use disorder).
  • Diagnosis of primary psychotic disorder.
  • Moderate-severe personality disorder.
  • Severe acute or chronic medical conditions.
  • Current or recent significant suicidal intent or self-harm behaviour.
  • Bladder pathology.
  • Inability to participate provide informed consent and/or participate in study procedures.
  • Pregnancy or lactation.
  • Prior serious head injury or other neurological condition causing ongoing cognitive impairment.
  • Young Mania Rating Scale (YMRS) > 8 (Young et al., 1978) (to rule out mixed states).
  • Previous poor response to ketamine.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment30 participants
  • Timeline
    Start: 2025-06-23
    End: 2027-02-22
  • Compound
    Ketamine
  • Topic
    Depressive Disorders

Locations

Unknown facility — Australia

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