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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004830-26-NL

Enrollment

Registered

2009-04-17

Start date

2009-08-27

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Major depressive disorder MedDRA version: 9.1 Level: LLT Classification code 10012399 Term: Depressive disorder

Interventions

Product Name: nortriptyline Pharmaceutical Form: Tablet INN or Proposed INN: NORTRIPTYLINE CAS Number: 72695 Concentration unit: mg milligram(s) Pharmaceutical form of the placebo: Tablet Route of adm

Eligibility

Sex/Gender

All

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 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

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
Main Objective: Does the combination of ECT with nortriptyline, compared with ECT alone, results in a more likely and faster response to ECT? ;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). Treatment phase II: relapse (HRSD > 14 and reduction HRSD score < 50%, CGI at least “much worse” compared to baseline), time to relapse.	—

Measure

Time frame

Main Objective: Does the combination of ECT with nortriptyline, compared with ECT alone, results in a more likely and faster response to ECT? ;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). Treatment phase II: relapse (HRSD > 14 and reduction HRSD score < 50%, CGI at least “much worse” compared to baseline), time to relapse.

—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026