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

• Status: Terminated
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hillerod Hospital, Denmark
• Treatments: Citalopram; Dexetimide; Nortriptyline

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