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Efficacy and memory problems following electroconvulsive therapy


- candidate number3251
- NTR NumberNTR1304
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-apr-2008
- Secondary IDsMETiGG no.: 6232 Assigned by the METiGG
- Public TitleEfficacy and memory problems following electroconvulsive therapy
- Scientific TitleEfficacy and memory problems following electroconvulsive therapy: a prospective study
- ACRONYMN/A
- hypothesisUltra-briefpulse (=pulsewidth 0.3 msec) ECT is equally efficacious as briefpulse (=pulsewidth 1 msec) ECT in its antidepressive action but causes less retrograde amnesia.
- Healt Condition(s) or Problem(s) studiedDepression, Memory, Electroconvulsive therapy, Pulsewidth
- Inclusion criteria1. 18 years or older
2. Major depression according to DSM IV criteria (APA, 1994) diagnosed with the (M.I.N.I.) Mini-international Neuropsychiatric Interview (Sheenan, Lecrubier, 1998)
3. Able to give informed consent
- Exclusion criteria1. History of alcohol or drugs abuse or dependence
2. History of head injury
3. Dementia according to CBO guidelines (NVKG, 2005)
4. Exclusion criteria according to the ECT-guidelines (NVvP, 2000)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2007
- planned closingdate1-apr-2013
- Target number of participants130
- InterventionsUltra-briefpulse ECT (=pulsewidth 0.3 msec) vs. briefpulse ECT (=pulsewidth 1 msec)
- Primary outcomeDepression scores assessed by the Montgomery Ăsberg Depression Rating Scale (MADRS)
- Secondary outcomeMemory score assessed by the Autobiographical Memory Interview (AMI)
- TimepointsDepression score: baseline, weekly for six weeks, end point after six weeks
Memory score: baseline, three weeks, end point after six weeks
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. A. Vrijburg
- CONTACT for SCIENTIFIC QUERIESDr. H.P. Spaans
- Sponsor/Initiator Parnassia, psycho-medische zorg, GGZ Delfland
- Funding
(Source(s) of Monetary or Material Support)
GGZ Delfland, Parnassia, psycho-medische zorg
- PublicationsN/A
- Brief summaryThe most important adverse effect of ECT is the occurrence of retrograde amnesia. This is a major obstacle for the more widespread use of the most efficacious treatment of depression.
Studies suggest that clinicians can manipulate the efficacy and amnesic effects of ECT to a certain degree by using different ECT techniques. In general the most efficacious forms of ECT also show more serious amnesic effects. A comparison of several ECT techniques is useful to confirm the findings from previous studies in different clinical settings.
In this study patients are randomised in two groups. In group one patients receive treatment with unilateral, ultra-briefpulse (=pulsewidth 0.3 msec) ECT, in group two patients receive treatment with unilateral, briefpulse (=pulsewidth 1 msec) ECT. The antidepressive action is assessed using depression rating scales and adverse cognitive effects are assessed using a neuropsychological test battery. Assessments are done single-blind.
- Main changes (audit trail)
- RECORD30-apr-2008 - 5-mei-2008


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