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

Conditions: Major depressive disorder
MedDRA version: 9.1Level: LLTClassification code 10012399Term: Depressive disorder

Registration Number: EUCTR2008-004830-26-NL

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does the combination of ECT with nortriptyline, compared with ECT alone, results in a more likely and faster response to ECT?<br>;Secondary Objective: ;Primary end point(s): Treatment phase I: mean reduction in HRSD-score, response (reduction HRSD score = 50%, CGI at least much improved” compared to baseline), time to response, remission (post ECT HRSD score = 7).<br>Treatment phase II: relapse (HRSD > 14 and reduction HRSD score < 50%, CGI at least much worse” compared to baseline), time to relapse.<br>

Secondary Outcome Measures