Ketamine Interleaved With Electroconvulsive Therapy for Depression
NCT ID: NCT04082858
Last Updated: 2021-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
3 participants
INTERVENTIONAL
2020-01-06
2020-06-03
Brief Summary
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Detailed Description
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Trial Interventions: participants will receive twice-weekly infusions of either ketamine at 0.5mg/Kg or midazolam at 0.045mg/Kg. All infusions will be administered by a Consultant Anaesthetist. Repeated infusions of allocated drug have been shown to be safe and well tolerated by patients with mental illness. Minor haemodynamic changes and psychotomimetic side effects can occur and will be assessed regularly during infusions and for 120 minutes afterwards. Participants will be followed-up at six weeks and three months after the final infusion to assess for relapse according to standardised criteria.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
QUADRUPLE
Study Groups
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Ketamine
Participants will receive twice-weekly infusions of ketamine at 0.05mg/kg for the duration of treatment with ECT. All infusions will be administered by a Consultant Anaesthetist.
Ketamine
A sub-anaesthetic dose of ketamine will be administered in twice-weekly infusions
Midazolam
Participants will receive twice-weekly infusions of midazolam at 0.045mg/kg for the duration of treatment with ECT. All infusions will be administered by a Consultant Anaesthetist.
Midazolam
A sub-anaesthetic dose of midazolam will be administered in twice-weekly infusions
Interventions
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Ketamine
A sub-anaesthetic dose of ketamine will be administered in twice-weekly infusions
Midazolam
A sub-anaesthetic dose of midazolam will be administered in twice-weekly infusions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* Voluntary admission for treatment of an acute depressive episode
* Meet DSM-V criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression)
* Montgomery Asberg Depression Rating Scale 10 item version (MADRS) score of ≥20
* Referred for treatment with ECT
* Sufficiently physically healthy to receive ketamine/midazolam and ECT
Exclusion Criteria
* Current involuntary admission
* History of Axis 1 diagnosis other than major depression
* Medical condition rendering unfit for ECT
* Active suicidal intention
* Presence of major neurological or organic brain disorder
* Alcohol/substance dependence in previous six-months
* Pregnancy or inability to confirm use of adequate contraception during the trial
* Breastfeeding women
* Contraindications to ketamine
* Contraindications to midazolam
18 Years
ALL
No
Sponsors
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St Patrick's Hospital, Ireland
OTHER
Responsible Party
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Prof Declan McLoughlin
Professor
Principal Investigators
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Declan McLoughlin, PhD
Role: PRINCIPAL_INVESTIGATOR
St Patrick's Hospital
Locations
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St Patrick's University Hospital
Dublin, Co. Dublin, Ireland
Countries
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Other Identifiers
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11/18
Identifier Type: -
Identifier Source: org_study_id
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