Does ECT in combination with nortriptyline result in a more likely and or faster response than ECT alone? Does continuation pharmacotherapy with nortriptyline result in a lower relapse rate or longer time to relapse in responders to ECT in…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Treatment phase I:
· Mean reduction in Hamilton Rating Scale for Depression (HRSD)-score
· Response (reduction HRSD score >= 50%, Clinical Global Impression (CGI) at
least *much improved* compared to baseline)
· Time to response
· Remission (post ECT HRSD score <= 7)
Treatment phase II:
· Relapse (HRSD > 14 and reduction HRSD score < 50%, CGI at least *much worse*
compared to baseline)
· Time to relapse
Secondary outcome
-
Background summary
About 50-60% of depressed inpatients treated with electroconvulsive therapy
(ECT) show response in an average of 6-8 weeks. ECT in combination with a
tricyclic antidepressant, instead of ECT alone, may enhance the efficacy of ECT
and decrease the time to response.
Despite continuation pharmacotherapy, relapse rate during one year following
ECT exceeds 50%. The combination of ECT with a tricyclic antidepressant and
continuation of this antidepressant after the course of ECT may decrease
relapse rate.
Some depressed inpatients show no suppression on the dexamethasone suppression
test, probably as a result of a higher hypothalamic-pituitary-adrenal axis
activity resulting in hypercortisolism. This can partly be explained by
differences in glucocorticoid sensitivity, which is influenced by polymorphisms
in the glucocorticoid receptor gene.
Study objective
Does ECT in combination with nortriptyline result in a more likely and or
faster response than ECT alone?
Does continuation pharmacotherapy with nortriptyline result in a lower relapse
rate or longer time to relapse in responders to ECT in combination with
nortriptyline compared to responders to ECT alone?
Study design
Treatment phase I: double blind placebo controlled study.
Treatment phase II: longitudinal follow-up study.
Intervention
Treatment phase I: one group receives ECT in combination with nortriptyline,
the other group ECT in combination with placebo.
Treatment phase II: all participating patients (responders treatment phase I)
receive nortriptyline.
Study burden and risks
The burden for participating patients is very low. The greater part of the
study is part of the standard procedure in the Erasmus MC and UMC Groningen
during hospitalisation and ECT treatment of patients with a depressive
disorder. The results can be of clinical relevance; a more likely and faster
response to ECT and reduction of relapse rate after successful ECT.
Postbus 2040
3000CA Rotterdam
NL
Postbus 2040
3000CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Major depressive disorder (DSM-IV-TR)
Hamilton Rating Scale for Depression >= 18
ECT indication
Age 18-80
If age >= 65 years, first depressive episode before age 65 and Mini Mental State Examination >= 24
At least 5 days free from medication before start doubble blind medication/ECT
Informed consent
Exclusion criteria
Alcohol- or drug dependence last 3 months
Serious neurologic illness
Endocrinologic illness affecting HPA-axis
Use of anti-epileptic medication
Bipolar disorder, schizoaffective disorder, schizophrenia
Contra-indication for nortriptyline
Pregnancy or possibility for pregnancy and no adequate contraceptive measures
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-0044830-2-NL |
| CCMO | NL23948.078.09 |