Ketamine as an Adjunctive Therapy for Major Depression

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-07

Study Completion Date

2018-09-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depressive Episode Unipolar Depression Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketamine

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

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

A sub-anaesthetic dose of ketamine will be administered in four infusions, each one week apart.

Midazolam

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

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

A sub-anaesthetic dose of midazolam will be administered in four infusions, each one week apart.

Interventions

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Ketamine

A sub-anaesthetic dose of ketamine will be administered in four infusions, each one week apart.

Intervention Type DRUG

Midazolam

A sub-anaesthetic dose of midazolam will be administered in four infusions, each one week apart.

Intervention Type DRUG

Other Intervention Names

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Ketalar Hypnovel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No