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…
ID
Bron
Aandoening
Major depression; nortriptyline; ECT; combination treatment; tricyclic antidepressants
Dutch keywords: Depressieve stoornis; nortriptyline; ECT; combinatie behandeling; tricyclische antidepressiva
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Mean change in HAM-D score<br>
Proportion of responders (≥ 50% reduction of HAM-D score)<br>
Proportion of remitters (final HAM-D score 7 or lower)
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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?
Onderzoeksopzet
HAM-D and CGI at baseline, weekly until the end of the ECT course.METC
Onderzoeksproduct en/of interventie
ECT + nortriptyline versus ECT + Placebo
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
• If age ≥ 65 ,first depressive episode before the age of 65.
• If age ≥ 65, intact cognitive functioning (MMSE 24)
• Informed consent (patient or their legal relatives, in case of in case of incapacity)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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..
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5346 |
| NTR-old | NTR5579 |
| Ander register | METC Erasmus MC : METC 2009-176 |