Major Depression
Conditions
Keywords
Major depression, relapse prevention, ECT, escitalopram, nortriptyline
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.
Interventions
DRUGescitalopram
10 mg daily
DRUGnortriptyline
100 mg daily dosage
Sponsors
Hillerod Hospital, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton depression rating scale | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Drop out due to side-effects of drugs | 14 days |
Countries
Denmark
Outcome results
None listed