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Optimization of the antidepressant effect of electroshock


- candidate number23522
- NTR NumberNTR5579
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-dec-2015
- Secondary IDsMETC 2009-176 
- Public TitleOptimization of the antidepressant effect of electroshock
- Scientific TitleOptimization of electroconvulsive therapy (ECT) and continuation pharmacotherapy in major depressive disorder
- ACRONYM
- hypothesisIs there a diiference in antidepressant efficacy between ECT and a combination of ECT and nortriptyline?
Does combination therapy with ECT and nortriptyline result in a faster antidepressant response compared with ECT monotherapy?
Does combination therapy result in less relapse after termination of the ECT course, compared with ECT monotherapy?
- Healt Condition(s) or Problem(s) studiedDepression, Electrical stimulation, Antidepressants
- Inclusion criteria Diagnosis Major depression according to DSM-IV-TR, established with depression part of the SADS
Baseline HAM-D score ≥ 18
Indication for treatment with ECT ( insufficient response during 4 weeks treatment with a tricyclic antidepressant with adequateplasmalevel or 4 weeks venlafaxine dosed 225 mg/day or higher)
Age 18-80
If age ≥ 65 ,first depressive episode before the age of 65.
If age ≥ 65, intact cognitive functioning (MMSE 24)
Drug-free during at least 5 days prior to start study medication
Informed consent (patient or their legal relatives, in case of in case of incapacity)
- Exclusion criteria Alcohol or drugdependecy during the last 3 months.
Severe neurological disorders.
Endocrinological disorders influencing HPA-axis
The use of antiepileptics.
Bipolar disorder, schizoaffective disorder or schizophrenia
Contraindication for nortriptyline
Pregnancy or inadequate contraception in fertile women.
Insufficient mastering of Dutch language..
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-jan-2018
- Target number of participants90
- InterventionsECT + nortriptyline versus ECT + Placebo
- Primary outcomeMean change in HAM-D score
Proportion of responders (≥ 50% reduction of HAM-D score)
Proportion of remitters (final HAM-D score 7 or lower)
- Secondary outcomeSpeed of response defined as the number of ECT sessions required for remission.
- TimepointsHAM-D and CGI at baseline, weekly until the end of the ECT course.METC
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdr. E.M. Pluijms
- CONTACT for SCIENTIFIC QUERIESdr. T.K. Birkenhager
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Lundbeck
- PublicationsN/A
- Brief summaryECT is a very effective treament for patients with severe major depression. However, it is unclear whether combining ECT with an antidepressant results in an increased efficacy and/or a faster antidepressant response. Furthermore, relapse following succesfull ECT is a relevant problem. Possibly combining ECT with an antidepressant may prevent some of the early relapse after ECT.
In this double-blind study patients are randomised to either treatment with ECT and nortriptyline or ECT and placebo. At baseline, and weekly thereafter the HAM-D and CGI are assessed, in order to determine response, remission, and the speed of response.
- Main changes (audit trail)
- RECORD22-dec-2015 - 14-feb-2016


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