TerminatedPhase 1ketamine
Ketamine for Relapse Prevention in Recurrent Depressive Disorder
Sponsored by St Patrick's Hospital, Ireland
NCT ID
NCT02661061
Target Enrollment
9 participants
Start Date
2015-12
Est. Completion
2018-05-23
About This Study
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.
Conditions Studied
Interventions
- •Ketamine
- •Midazolam
Eligibility
Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility 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
Study Locations (1)
St Patrick's University Hospital
Dublin, Ireland