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

Phase 4

Terminated

• Conditions: Major Depression
• Interventions: Drug: escitalopram; Drug: nortriptyline

• Registration Number: NCT00660062
• Lead Sponsor: Hillerod Hospital, Denmark

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.

Study Timeline

• Study First Submitted: 2008-04-14
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-17
• Study Start: 2009-08
• Status Verified: 2011-04
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-12-07
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Escitalopram 10 mg daily	escitalopram	Escitalopram 10 mg daily
escitalopram 30 mg daily	escitalopram	escitalopram 30 mg daily
Escitalopram 20 mg daily	escitalopram	Escitalopram 20 mg daily
Nortriptylin 100 mg daily	nortriptyline	Nortriptylin 100 mg daily

Primary Outcome Measures

Name	Time	Method
Hamilton depression rating scale	14 days

Secondary Outcome Measures

Name	Time	Method
Drop out due to side-effects of drugs	14 days

Trial Locations

Locations (1)

Mental Health Centre Copenhagen Department O; 🇩🇰 Copenhagenl, Denmark