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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33909

Enrollment

Registered

2009-05-25

Start date

2010-03-10

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

depression Major depression

Interventions

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 pha

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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 14 and reduction HRSD score	—

Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)