Relapse Prevention With Escitalopram or Nortriptyline Following Electro-Convulsive Treatment (DUAG-7)

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to investigate the relapse preventing efficacy of escitalopram in a dose range and nortriptylin in a single dose in patients having been treated successfully with a course of electroconvulsive treatment (ECT).

Detailed Description
-----------------
This study records severity of depression and relapse in patients treated for a major depressive disorder with electroconvulsive treatment (ECT)in a period og 6 month after end of ECT treatment. Patients will be randomized into four groups treated with escitalopram 10 mg, 20 mg, 30 mg or nortriptylin 100 mg daily dosages. The primary outcome measure is relapse and secondary outcome measure is tolerability. The study is a multicenter trial within Denmark.

Official Title
-----------------
Relapse Prevention in Patients With a Major Depressive Episode Treated With Electroconvulsive Treatment Using a Fixed Dose Range of Escitalopram Compared to a Fixed Dose of Nortriptyline (DUAG-7) A Randomised Controlled 6 Month Double-blind Study

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Drug: escitalopram
* Drug: escitalopram
* Drug: escitalopram
* Drug: nortriptyline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Remission from a major depressive episode after ECT treatment Exclusion Criteria: Suicidality (Hamilton item 3 score of 3 or more) Symptoms mania (MAS score of 15 or more) Duration of actual depressive episode more than 2 years Compulsory measures of any kind Dementia Severe somatic illness Pregnant or lactating subject Known clinical relevant malabsorption. Epilepsia Clinically substantial cognitive deterioration due to ECT treatment schizophrenia, schizopreniform or schizo-affective disorder Bipolar I, Bipolar II eller Rapid cycling bipolar disorder Abuse of alcohol or drugs Early relapse (less than 2 month) after ECT Inadequate contraception Known intolerance to any of the used study medications Myocardial infarction in the last 6 month Clinical important liver disease Any known disturbance of the cardiac conduction system, cardiac insufficiency,or other clinical important cardiac disease Treatment with a MAO-inhibitor Treatment with norepinephrine or epinephrine Known hyperthyroidism or treatment with thyroid hormones Known ortostatic hypertension. Glaucoma Known hereditary galactoseintolerance, Lapp Lactase deficiency) or gluco-se/galactosemalabsorption. Ongoing treatment with sympatomimetica efedrine, isoprenaline, physostigmine, dopamine, levodopa, phenylephrine. Ongoing treatment with anticholinergica, antiparkinson treatment, antihistamines, atropine, biperiden, Ongoing treatment with drugs that prolongs the cardiac QT-interval, such as quinidine, antihistamines, terfenadine og sotalole Ongoing treatment with fluconazole or terbinafine Ongoing treatment with mefloquin. Known intolerance to escitalopram Ongoing treatment with serotonergic acting substances such as tramadole, sumatriptane

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram 10 mg daily<br>Escitalopram 10 mg daily | Drug: escitalopram<br>* 10 mg daily<br>|
| Experimental: Escitalopram 20 mg daily<br>Escitalopram 20 mg daily | Drug: escitalopram<br>* 20 mg daily dosage<br>|
| Experimental: escitalopram 30 mg daily<br>escitalopram 30 mg daily | Drug: escitalopram<br>* 30 mg daily dosage<br>|
| Active Comparator: Nortriptylin 100 mg daily<br>Nortriptylin 100 mg daily | Drug: nortriptyline<br>* 100 mg daily dosage<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton depression rating scale |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop out due to side-effects of drugs |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major depression, relapse prevention, ECT, escitalopram, nortriptyline