Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
NCT ID:
NCT02661061
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02661061
Study Brief:
Protocol Section:
NCT02661061