Ketamine for Relapse Prevention in Recurrent Depressive Disorder

• Status: Terminated
• Trial end date: 2018-05-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St Patrick's Hospital, Ireland
• Treatments: Ketamine; Midazolam

Criteria

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