Ketamine Interleaved With Electroconvulsive Therapy for Depression

NCT04082858 | Terminated Phase 1 DMC

• 1 other identifier: 11/18
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Pragmatic, randomised, controlled, parallel group, pilot clinical trial of ketamine vs. midazolam interleaved with electroconvulsive therapy (ECT) as an adjunctive treatment for a major depressive episode. The main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.

Conditions

Depression

Keywords

Ketamine; Electroconvulsive Therapy; Depression; ECT

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale (MADRS)

  A validated, 10-item, depression rating scale to measure depressive symptomatology and response to treatment. During the infusion sessions MADRS scores will be obtained immediately pre-infusion and at +60 and +120 minutes afterwards. Depression measures will be repeated at week 6 and at three-months post infusion. This outcome measure assesses the change in MADRS scores during the pilot trial. A course of ECT can be prescribed for a maximum to 6 weeks (12 sessions in total, twice weekly for 6 weeks). Trial infusions will be administered twice weekly on separate days to ECT, for the duration of treatment with ECT. Therefore, trial infusions may be administered for up to 6 weeks. Participants will be followed up for three months (12 weeks) after their final infusion. In total, participants outcome measures will be repeated for up to 18 weeks.

  18 weeks

Secondary Outcomes (6)

• The Quick Inventory of Depressive Symptoms, self-report version (QIDS-SR16)

  18 weeks

• The Clinician-Administered Dissociative States Scale (CADSS)

  6 weeks

• The Brief Psychiatric Rating Scale (BPRS)

  6 weeks

• Young Mania Rating Scale (YMRS; mood item)

  6 weeks

• The Patient-Rated Inventory of Side Effects (PRISE)

  6 weeks

Study Arms (2)

Ketamine

EXPERIMENTAL

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.

Drug: Ketamine

Midazolam

ACTIVE COMPARATOR

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.

Drug: Midazolam

Interventions

Ketamine DRUG

A sub-anaesthetic dose of ketamine will be administered in twice-weekly infusions

Also known as: Ketalar

Ketamine

Midazolam DRUG

A sub-anaesthetic dose of midazolam will be administered in twice-weekly infusions

Also known as: Hyponovel

Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• 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

You may not qualify if:

• Inability to provide informed consent
• 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

Sponsors & Collaborators

• St Patrick's Hospital, Ireland: lead

Study Sites (1)

St Patrick's University Hospital

Dublin, Co. Dublin, D08 K7YW, Ireland

Location

MeSH Terms

Conditions

Depression

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Declan McLoughlin, PhD

  St Patrick's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pragmatic, randomised, controlled, parallel group, pilot clinical trial

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: September 9, 2019
• Study Start: January 6, 2020
• Primary Completion: June 3, 2020
• Study Completion: June 3, 2020
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)