Depressive disorder, cognitive side-effects
Conditions
Interventions
Note: target sample size=250 for cohort, in order to include n=38 for trial.
Intervention:
After inclusion (e.g. the occurrence of interictal delirium), the randomized, placebo-controlled cross-over
Sponsors
Amsterdam UMC
Eligibility
Inclusion criteria
Inclusion criteria: 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. Inclusion in rivastigmine-trial: Next, the occurrence of an interictal delirium is assessed by the Confusion Assessment method (CAM)) and Mini Mental State Examination (MMSE)). The CAM and MMSE are recorded as a routine follow-up in all ECT-cases by a trained research assistant or trained nurse, in general at Wednesday (if ECT is performed twice weekly at Tuesday and Friday). Participants with a CAM-score, indicating delirium, will be included in the trial. For a diagnosis of delirium by CAM, the patient must display: 1) Presence of acute onset and fluctuating discourse, and 2) Inattention, and either 3) Disorganized thinking or 4) Altered level of consciousness (Inouye et al., 1990). The MMSE is a screening instrument for measuring the severity of cognitive impairment with good interrater and test-retest reliability (Folstein et al., 1975; Cockrell et al., 1988). Officially, the MMSE is not validated as a diagnostic tool for assessing delirium, but in our opinion it is a useful tool in our study population to diagnose interictal delirium. We claim, based on our clinical experience that interictal delirium not always behaves as a 'regular' delirium and therefore does not always meet the criteria for delirium as measured with the CAM. Hence, by screening for interictal delirium only using the CAM, eligible patients for the trial might be missed. Persons with delirium according to the CAM score or persons with a change in total MMSE-scores of -4 during ECT are eligible for inclusion in the rivastigmine trial.
Exclusion criteria
Exclusion criteria: 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. Rivastigmine trial: Exclusion criteria for rivastigmine-trial are prior participation in the study (in case of relapse of the depression requiring a new ECT course), bradycardia or AV conduction disorder (first degree AV-block excluded), already use of rivastigmine, galantamine or donepezil (all cholinesterase inhibitors for mild to moderate Alzheimers disease) or any previous allergic or adverse reactions to rivastigmine. Also individuals who switch from right unilateral electrodeplacement (RUL) to bilateral electrodeplacement (BL) during trial will be excluded.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - 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. - Adverse/ side effects of rivastigmine. - 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. | — |
Primary
| Measure | Time frame |
|---|---|
| Impact of rivastigmine on: 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. 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. | — |
Contacts
Public ContactD. Rhebergen
GGZ inGeest, De Nieuwe valerius;
Outcome results
None listed