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

Recruiting

Conditions: depression
Major depression
10027946

Registration Number: NL-OMON33909

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Treatment phase I:<br /><br>· Mean reduction in Hamilton Rating Scale for Depression (HRSD)-score<br /><br>· Response (reduction HRSD score >= 50%, Clinical Global Impression (CGI) at<br /><br>least much improved compared to baseline)<br /><br>· Time to response<br /><br>· Remission (post ECT HRSD score <= 7)<br /><br><br /><br>Treatment phase II:<br /><br>· Relapse (HRSD > 14 and reduction HRSD score < 50%, CGI at least much worse<br /><br>compared to baseline)<br /><br>· Time to relapse</p><br>

Secondary Outcome Measures