Status:
TERMINATED
Relapse Prevention With Escitalopram or Nortriptyline Following Electro-Convulsive Treatment (DUAG-7)
Lead Sponsor:
Hillerod Hospital, Denmark
Conditions:
Major Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 c...
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. Patie...
Eligibility Criteria
Inclusion
- Remission from a major depressive episode after ECT treatment
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00660062
Start Date
August 1 2009
End Date
November 1 2014
Last Update
December 9 2014
Active Locations (1)
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1
Mental Health Centre Copenhagen Department O
Copenhagenl, Denmark, 2100 Ø