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Optimization of the antidepressant effect of electroshock

Optimization of electroconvulsive therapy (ECT) and continuation pharmacotherapy in major depressive disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20033
Enrollment
90
Registered
2015-12-22
Start date
2010-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depression

Interventions

ECT + nortriptyline versus ECT + Placebo

Sponsors

Erasmus MC Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

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 • 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)

Exclusion criteria

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..

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Speed of response defined as the number of ECT sessions required for remission.

Contacts

Public ContactE.M. Pluijms

Erasmus MC

e.pluijms@erasmusmc.nl+31107033636

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)