Ketamine as an Adjunctive Therapy for Major Depression (KARMA-dep)

St Patrick's Hospital, Ireland

Status and phase: Completed; Phase 1

Conditions: Major Depressive Episode; Bipolar Depression; Unipolar Depression

Treatments: Drug: Midazolam; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03256162

01/17

2016-004764-18 (EudraCT Number)

Details and patient eligibility

About

Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam as an adjunctive therapy for depression. The main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.

Full description

Pragmatic, randomised, controlled, parallel-group, pilot trial. Trial participants will be patients admitted to St Patrick's University Hospital for treatment of a depressive episode. The investigators aim to recruit up to 20 participants who will be eligible for this study and randomly allocate 10 patients to each group. The participants will undergo usual inpatient care as prescribed by their treating team for the index acute depressive episode. Both participants and assessors will be blind to treatment allocation. Consented participants will be randomly allocated in a 1:1 ratio to a four week course of either once-weekly ketamine or midazolam infusions. Block randomisation will be independently performed. Physical, psychotomimetic and cognitive outcomes will be monitored before, during and after infusions. Blood samples will be taken at four time-points in the first infusion session and before the final infusion for neuroplasticity biomarker studies. Both groups will continue treatment as usual. Participates will also be followed up over a three month period.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years old
• Hamilton Rating Scale for Depression-24 item version (HRSD-24) score of ≥21
• Voluntary admission for treatment of an acute depressive episode
• Meet Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-V) criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression)

Exclusion criteria

• Current involuntary admission
• Medical condition rendering unfit for ketamine/midazolam
• Active suicidal intention
• Dementia
• History of Axis 1 diagnosis other than major depression
• Electroconvulsive Therapy (ECT) administered within the last two months
• Alcohol/substance dependence in previous six-months
• Pregnancy or inability to confirm use of adequate contraception during the trial
• Breastfeeding women

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups

Ketamine

Experimental group

Description:

Participants will receive four once-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.

Treatment:

Drug: Ketamine

Midazolam

Active Comparator group

Description:

Participants will receive four once-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.

Treatment:

Drug: Midazolam