Rivastigmine treatment for electroconvulsive therapy- induced confusion in elderly depressed patients
- Conditions
- Interictal delirium during electric convulsive therapy- courseTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2014-003385-24-NL
- Lead Sponsor
- GGZ inGeest, parner VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 38
- Patient is admited at the in-wards of one of the participating psychiatric hospitals
- Patients fulfilling the Composite International Diagnostic Interview (CIDI) criteria of a Major Depressive Episode (not necessarily in the context of a Major Depressive Disorder only)
- Patient is indicated for ECT-treatment.
- Patient or legal representitive is able to give informed consent
- Occurence of an interictal delirium is assessed by the Confusion Assessment method (CAM) and/ or 4 pts drop Mini Mental State Examination score (MMSE)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38
- Patients not meeting the inclusion criteria
- Patient has a comorbid medical condition that is a contraindication for ECT according to the prevailing Dutch ECT-guidelines
- Current use of rivastigmine or an other cholinesterase inhibitor
- Known intolerance of rivastigmine or an other cholinesterase inhibitor
- Bradycardia or AV conduction disorder at baseline ECG (first degree AV block exluded)
- switch from right unilateral electrodeplacement (RUL) to bilateral electrodeplacement (BL) during trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method