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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00660062
Recruitment Status : Terminated (Slow inclusion)
First Posted : April 17, 2008
Last Update Posted : December 9, 2014
Information provided by (Responsible Party):
Klaus Martiny, Hillerod Hospital, Denmark

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).

Condition or disease Intervention/treatment Phase
Major Depression Drug: escitalopram Drug: nortriptyline Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : August 2009
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
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

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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: April 2011

Keywords provided by Klaus Martiny, 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