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

December 7, 2014 updated by: Klaus Martiny, Hillerod Hospital, Denmark

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

47

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagenl, Denmark, 2100 Ø
        • Mental Health Centre Copenhagen Department O

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Escitalopram 10 mg daily
Drug: escitalopram
10 mg daily
Drug: escitalopram
20 mg daily dosage
Drug: escitalopram
30 mg daily dosage
Experimental: Escitalopram 20 mg daily
Drug: escitalopram
10 mg daily
Drug: escitalopram
20 mg daily dosage
Drug: escitalopram
30 mg daily dosage
Experimental: escitalopram 30 mg daily
Drug: escitalopram
10 mg daily
Drug: escitalopram
20 mg daily dosage
Drug: escitalopram
30 mg daily dosage
Active Comparator: Nortriptylin 100 mg daily
Drug: nortriptyline
100 mg daily dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton depression rating scale
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Drop out due to side-effects of drugs
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillerod Hospital, Denmark

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 7, 2014

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUAG-7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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