Rivastigmine for ECT-induced Cognitive Adverse effects in Late Life Depression:a multicenter, randomized, double-blind, placebo-controlled, crossover trial
- Conditions
- Depressive disorder, cognitive side-effects
- Registration Number
- NL-OMON23967
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
Patients, aged 55 years or older, fulfilling the Composite International Diagnostic Interview (CIDI) criteria of a Major Depressive Episode (not necessarily in the context of a Major Depressive Disorder only) and indicated for ECT-treatment will be asked to participate in the study. Written informed consent will be obtained from each patient, or- in case of inability to consent - will be obtained by his legal representative.
Exclusion criteria are comorbid medical conditions that are a contraindication for ECT according to the prevailing Dutch ECT-guidelines (Van den Broek et al., 2010). Also, in case of prior participation in the study (in case of relapse of the depression requiring a new ECT course), the patient will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Impact of rivastigmine on:<br /><br>1.Scores on Delirium Rating Scale (DRS-98)(Van der Mast et al., 2004), assessed after two ECT sessions with rivastigmine, compared with DRS-98 outcomes assessed after two ECT sessions without rivastigmine.<br /><br>2.Scores on cognitive functioning tests (MMSE, fluency, clock-drawing-test), assessed after two ECT sessions with rivastigmine, compared with outcomes assessed after two ECT sessions without rivastigmine.<br>
- Secondary Outcome Measures
Name Time Method - Impact of rivastigmine on several ECT characteristics measured (blood pressure, heart rate, seizure length, post ictal suppression index, seizure threshold, type of anesthetics and dosage) during ECT.<br /><br>- Adverse/ side effects of rivastigmine.<br /><br>- Profiles of confusional states based on scores on reorientation time, Richmond Agitation Sedation Scale (RASS), Confusion Assessment Methods (CAM)/Delirium Rating Scale (DRS-98), MMSE, fluency, clock-drawing-test, all assessed during ECT, and their determinants.<br>