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 @ 9:41 PM
Ignite Modification Date:
2025-12-24 @ 9:41 PM
NCT ID:
NCT02414932
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥18 years with unipolar major depressive disorder (DSM-IV)
* 24-item Hamilton Rating Scale for Depression (HRSD-24) score of ≥21
* Referred for ECT
For the randomised Phase 2, patients must have
* received a substantial course of ECT in Phase 1 (i.e. at least five sessions)
* achieved at least response criteria (i.e. ≥60% decrease from baseline HRSD-24 score and score ≤16 on two consecutive weekly ratings)
* have a nominated adult who can stay with them for 24-hours on out-patient treatment days
* Mini-Mental State Examination (MMSE) score of ≥24
* able to provide informed consent
Exclusion Criteria:
* Any condition rendering patient medically unfit for ECT; general anaesthesia, ketamine or midazolam - assessed by physical examination, routine haematology and biochemistry investigations prior to enrolment in Phase I (routine care)
* Active suicidal intention
* Dementia, intellectual disability, or MMSE \<24
* Lifetime history of bipolar affective disorder
* Current history of post-traumatic stress disorder
* Other Axis I diagnosis (DSM-IV)
* ECT in the six months prior to recruitment
* Alcohol dependence or substance misuse in the six months prior to recruitment
* Pregnancy or breast-feeding
* Residing in a nursing home
* Prisoner
* Diagnosis of terminal illness
* Inability or refusal to provide valid informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02414932
Study Brief:
Protocol Section:
NCT02414932