Clinical TrialTreatment-Resistant Depression (TRD)KetamineKetamineNot yet recruiting

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

Randomised, parallel-group trial (n=60) comparing oral ketamine plus Behavioural Activation Therapy (BAT) vs oral ketamine plus treatment as usual in adults with treatment-resistant major depressive disorder; oral ketamine initial 0.5 mg/kg (up to 2 mg/kg) sipped over 30–60 minutes.

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

Detailed Description

This parallel, randomised interventional trial enrolls adults with treatment‑resistant major depressive disorder to receive oral ketamine with either a structured Behavioural Activation Therapy programme or treatment as usual; ketamine dosing begins at 0.5 mg/kg (oral, diluted and sipped) with potential escalation to 1.5 and 2 mg/kg based on MADRS and tolerability.

BAT comprises 12 sessions (twice-weekly for 4 weeks then weekly for 4 weeks), timed within 24 hours of ketamine treatments, and is adapted (including He Puna Whakaata principles for Māori). Feasibility, retention, acceptability, depressive symptoms, and cognitive outcomes (MATRICS battery at baseline and 7 days post‑ketamine treatment) will be assessed.

Study Protocol

Preparation

sessions

Dosing

12 sessions
60 min each

Integration

12 sessions
45 min each

Therapeutic Protocol

cbt

Study Arms & Interventions

Ketamine + BAT

experimental

Oral ketamine combined with Behavioural Activation Therapy (BAT).

Interventions

  • Ketamine0.5 - 2 mg/kg
    via Oral• twice weekly (initial)• 12 doses total

    Diluted in 50 ml orange juice and sipped over 30–60 minutes; dose may be escalated to 1.5 then 2 mg/kg per MADRS and tolerability; dosing individualised.

Ketamine + TAU

active comparator

Oral ketamine with Treatment As Usual (nursing contact/support) as comparator.

Interventions

  • Ketamine0.5 - 2 mg/kg
    via Oral• twice weekly (initial)• 12 doses total

    Same ketamine dosing regimen as experimental arm; TAU comprises nursing contact on dosing days and telephone support.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Age 18–65 years; treatment-resistant DSM-5 Major Depressive Disorder (TR-MDD), defined as failure to respond to at least two antidepressant medications at adequate doses for >6 weeks; HAMD-17 >16 at screening; on stable medication treatment (or no treatment) for ≥1 month prior to screening and willing to remain on same medication during active treatment; proficient in spoken English.

Exclusion Criteria

  • Severe acute or chronic medical conditions (e.g. diabetes, ischaemic heart disease, COPD, cerebro-vascular disease); past or current 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 history of allergic skin reactions; prior serious head injury or neurological condition causing ongoing cognitive impairment; pregnant or breastfeeding; receiving active psychotherapy for MDD (supportive psychotherapy may be placed on hold); receipt of a course of BAT in the last 12 months or prior non-response to BAT or ketamine; ECT in the last 6 months.

Study Details

Locations

Unknown facility — Australia

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