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TerminatedPhase 1Results posted

Ketamine for Relapse Prevention in Recurrent Depressive Disorder

NCT02661061 · KINDRED · St Patrick's Hospital, Ireland

Closed to entry
Status
Not accepting participants
Phase 1
Phase
9
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam for depression relapse prevention in persons at high risk. The main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Completion Rate for Randomised Treatment Phase

    Measured over 2 years

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * ≥18 years old * Hamilton Rating Scale for Depression, 24-item (HRSD-24) score of ≥21 * Voluntary admission for treatment of acute depressive episode * Meet DSM-IV criteria for recurrent depressive disorder (RDD): ≥2 previous depressive episodes with at least 2-months(consecutive) subthreshold or no symptoms in between PLUS(to enrich the sample for those at high risk for relapse) must also have experienced ≥3 major depressive episodes(including index episode) within the previous 2 years For the randomised pilot trial, RDD patients must have: * received antidepressant treatment for the acute depressive episode(pharmacological, psychotherapeutic or multidisciplinary) * ≥60% decrease from baseline HRSD-24 score and score ≤16 * Standardised Mini-Mental State Examination (sMMSE) score of ≥24 * able to provide informed consent Exclusion Criteria: * Current involuntary admission * Medical condition rendering unfit for ketamine/midazolam * Active suicidal intention * Dementia * History of Axis 1 diagnosis other than RDD * Electroconvulsive therapy (ECT) for treatment of current depressive episode * Alcohol/substance abuse in previous six months * Pregnancy or inability to confirm use of adequate contraception during the trial

Where

1 study site

FacilityCityRegionCountry
St Patrick's University HospitalDublinIreland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT02661061 on ClinicalTrials.gov →

Last updated in the registry 2020-01-13. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits