|- candidate number||23522|
|- NTR Number||NTR5579|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-dec-2015|
|- Secondary IDs||METC 2009-176 |
|- Public Title||Optimization of the antidepressant effect of electroshock|
|- Scientific Title||Optimization of electroconvulsive therapy (ECT) and continuation pharmacotherapy in major depressive
|- hypothesis||Is 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) studied||Depression, 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2011|
|- planned closingdate||1-jan-2018|
|- Target number of participants||90|
|- Interventions||ECT + nortriptyline versus ECT + Placebo|
|- Primary outcome||Mean 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 outcome||Speed of response defined as the number of ECT sessions required for remission.|
|- Timepoints||HAM-D and CGI at baseline, weekly until the end of the ECT course.METC|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||dr. E.M. Pluijms|
|- CONTACT for SCIENTIFIC QUERIES||dr. T.K. Birkenhager|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Lundbeck|
|- Brief summary||ECT 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)|
|- RECORD||22-dec-2015 - 14-feb-2016|