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

This study has been terminated.
(Slow inclusion)
Information provided by (Responsible Party):
Klaus Martiny, Hillerod Hospital, Denmark Identifier:
First received: April 14, 2008
Last updated: December 7, 2014
Last verified: April 2011
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).

Condition Intervention Phase
Major Depression
Drug: escitalopram
Drug: nortriptyline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Hamilton depression rating scale [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Drop out due to side-effects of drugs [ Time Frame: 14 days ]

Enrollment: 47
Study Start Date: August 2009
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escitalopram 10 mg daily
Escitalopram 10 mg daily
Drug: escitalopram
10 mg daily
Experimental: Escitalopram 20 mg daily
Escitalopram 20 mg daily
Drug: escitalopram
20 mg daily dosage
Experimental: escitalopram 30 mg daily
escitalopram 30 mg daily
Drug: escitalopram
30 mg daily dosage
Active Comparator: Nortriptylin 100 mg daily
Nortriptylin 100 mg daily
Drug: nortriptyline
100 mg daily dosage

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00660062

Mental Health Centre Copenhagen Department O
Copenhagenl, Denmark, 2100 Ø
Sponsors and Collaborators
Hillerod Hospital, Denmark
Principal Investigator: Klaus Martiny, MD,PhD Mental Health Center Copenhagen Department O
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Klaus Martiny, Senior Consultant, Hillerod Hospital, Denmark Identifier: NCT00660062     History of Changes
Other Study ID Numbers: DUAG-7
Study First Received: April 14, 2008
Last Updated: December 7, 2014

Keywords provided by Hillerod Hospital, Denmark:
Major depression
relapse prevention

Additional relevant MeSH terms:
Depressive Disorder, Major
Behavioral Symptoms
Disease Attributes
Pathologic Processes
Depressive Disorder
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents processed this record on April 21, 2017