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

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”

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).

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.

Intervention(s) in this Clinical Trial

• Drug: escitalopram
  • 10 mg daily
• Drug: escitalopram
  • 20 mg daily dosage
• Drug: escitalopram
  • 30 mg daily dosage
• Drug: nortriptyline
  • 100 mg daily dosage

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Escitalopram 10 mg daily
  • Escitalopram 10 mg daily
• Experimental: Escitalopram 20 mg daily
  • Escitalopram 20 mg daily
• Experimental: escitalopram 30 mg daily
  • escitalopram 30 mg daily
• Active Comparator: Nortriptylin 100 mg daily
  • Nortriptylin 100 mg daily

Primary Measures

• Hamilton depression rating scale
  • Time Frame: 14 days
    Safety Issue?: No

Secondary Measures

• Drop out due to side-effects of drugs
  • Time Frame: 14 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Hillerod Hospital, Denmark Other

Overall Clinical Trial Officials and Contacts

Klaus Martiny, MD,PhD Principal Investigator Mental Health Center Copenhagen Department O  

Overall Contact: Klaus Martiny, Ph.D. 45-4829-3237 kmar@noh.regionh.dk

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00660062

Study ID Number: DUAG-7

ClinicalTrials.gov Identifier: NCT00660062

Health Authority: Denmark: Danish Medicines Agency

homepage for the DUAG organization