Relapse prevention in patients with major depression treated with electroconvulsive therapy using a fixed dose range of escitalopram compared to a fixed dose of nortriptyline (DUAG-7)A randomised controlled 6 month double-blind study - Relapse prevention with escitalopram or nortriptyline following ECT (DUAG-7)
- Conditions
- Major depressionMedDRA version: 14.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders
- Registration Number
- EUCTR2008-003877-42-DK
- Lead Sponsor
- Danish University Antidepressant Group (DUAG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
•Remission of depression after Electroconvulsive Therapy (ECT)
•Age above 18
•ECT course ended within the last 21 days
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
•Suicidality corresponding to more than a score of more than 3 on the Hamilton depressionsskale item 3 or if project participant or investigator cannot determine the level of suicidality.
•Manic symptoms of a severety corresponding to a score of 15 or more on the Bech-Rafaelsen Mania scale at inclusion and at any time during the study period.
•Duration of current depressive episode of more than 2 years.
•Participant is under coercive measures.
•Dementia or any other known organic brain disease than is anticipated to influence the validity of the informed consent and compliance with the study.
•Presence of known clinical important somatic diseases supposed to be problematic in relation to study procedures.
•Epilepsia.
•Cognitive deterioration caused by the Electroconvulsive therapy supposed to be problematic in relation to study procedures.
• Schizophrenia, schizoaffektive disorder or other psychotic disorder without relation to actual depressive episdoe.
•Bipolar I, Bipolar II or Rapid cy-cling bipolar sygdom.
•Abuse of alcohol or other non-prescribed use of benzodiazepines
•Current treatment with fluoxetine or within the last 6 weeks
•Pregnancy or lactating.
•Insufficient contraception.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method