Clinical TrialDepressive DisordersKetamineRecruiting

Ketamine versus Ketamine plus Behavioural Activation Therapy for Adults with Treatment Resistant Depression

This randomised controlled parallel group trial (n=60) evaluated the safety and efficacy of ketamine for treatment resistant depression using 35mg/70kg ketamine.

Target Enrollment
60 participants
Study Type
interventional
Design
Randomized, single Blind

Detailed Description

Our study will compare oral ketamine treatment with oral ketamine treatment and Behavioural Activation Therapy (BAT) for patients with treatment resistant depression.

We will test the feasibility of providing oral ketamine and BAT over 8 weeks in a study. We hypothesise that adding BAT to oral ketamine treatment will prolong the response and delay relapse for three months after treatment ends. We also hypothesise that BAT and oral ketamine will be well tolerated by participants.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Ketamine

Participants

Inclusion Criteria

  • Participants aged between 18 and 65 years with treatment-resistant, DSM 5, Major Depressive Disorder (TR-MDD) are eligible for entry to the study. A standard definition for treatment resistance will be used: having trialled, and not responded to, at least two antidepressant medications at adequate doses for more than 6 weeks.
  • At screening, patients will have a Hamilton Depression Rating Scale-17 (HAMD) greater than 16, reflecting depression of at least moderate severity.
  • Participants will be required to be on stable medication treatment (or no treatment) for at least 1 month prior to screening for the study and commit to remaining on the same medication during active treatment to ensure treatment withdrawal or dose changes do not confound study effects.
  • Proficient in spoken English

Exclusion Criteria

  • Evidence of severe acute or chronic medical conditions (e.g. diabetes, ischaemic heart disease, chronic obstructive airways disease, cerebro-vascular disease);
  • Past or current diagnoses of schizophrenia, bipolar disorder, or current psychotic symptoms; moderate-severe personality disorder;
  • Current or recent significant suicidal ideation;
  • Current or recent (past 6 months) substance use disorder;
  • Prior history of seizures; susceptibility to photosensitivity; or a history of allergic skin reactions; prior history of serious head injury or other neurological condition resulting in ongoing cognitive impairment;
  • Participants who are breast feeding or pregnant
  • Receiving active psychotherapy for MDD (supportive psychotherapy can be placed on hold during the study)
  • Having received a course of BAT in the last 12 months; previous non-response to BAT or Ketamine treatment
  • Electro-Convulsive Therapy (ECT) in the last 6 months.

Study Details

  • Status
    Recruiting
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment60 participants
  • Timeline
    Start: 2024-02-05
    End: 2026-03-02
  • Compound
    Ketamine
  • Topic
    Depressive Disorders

Locations

Unknown facility — Australia

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