Clinical trial NCT03256162: Ketamine as an Adjunctive Therapy for Major Depression
Official title: Ketamine as an Adjunctive Therapy for Major Depression - a Randomised Controlled Pilot Trial: The KARMA-Dep Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Episode
Unipolar Depression
Bipolar Depression
Keywords: ketamine
glutamate
Lead sponsor: St Patrick's Hospital, Ireland
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Hamilton Rating Scale for Depression-24 Item Version (HRSD-24)
timeFrame: 15 weeks
Secondary outcomes:
measure: The Quick Inventory of Depressive Symptoms, Self-report Version (QIDS-SR16)
timeFrame: 15 weeks
measure: The Clinician-Administered Dissociative States Scale (CADSS)
timeFrame: 4 weeks
measure: The Brief Psychiatric Rating Scale (BPRS)
timeFrame: 4 weeks
measure: Young Mania Rating Scale (YMRS; Mood Item)
timeFrame: 4 weeks
measure: The Patient-Rated Inventory of Side Effects (PRISE)
timeFrame: 4 weeks
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St Patrick's University Hospital
Study officials:
affiliation: St Patrick's Mental Health Services and Trinity College Dublin
name: Declan M McLoughlin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallagher B, Foley M, Slattery CM, Gusciute G, Shanahan E, McLoughlin DM. Ketamine as an adjunctive therapy for major depression - a randomised controlled pragmatic pilot trial (Karma-Dep Trial). HRB Open Res. 2022 Jan 27;3:90. doi: 10.12688/hrbopenres.13182.2. eCollection 2020.