Major depression MedDRA version: 14.0 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: cipralex
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Escitalopram
CAS Number: 219861082
Other descriptive name: ESCITALOPRAM OXALATE
Concentration unit: mg milligram(s)
Concent
Sponsors
Danish University Antidepressant Group (DUAG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the DUAG-7 trial is to investigate, in a multicentre randomised controlled trial with double-blinding, whether it is possible to reduce depression relapse after successful ECT by using the newer SSRI medication escitalopram with nortriptylin as an active comparator. Patients are randomised into four groups with three individual fixed dosages of escitalopram and a single optimal dose of nortriptyline.;Secondary Objective: To establish the optimal relapse prevention dosage of escitalopram in a 6-month follow-up period after ECT. To establish the tolerability of individual dosages of escitalopram and nortriptyline. ;Primary end point(s): Primary endpoint is the number of patients developing relapse within a 6-month period after the final ECT. Relapse is defined as a score of more that 15 on the Hamilton Depression Rating Scale. Secondary endpoint is drop-out due to treatment-emergent side effects. | — |
Countries
Denmark
Outcome results
None listed