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

Primary Purpose

Major Depression

Status
Terminated
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
escitalopram
escitalopram
escitalopram
nortriptyline
Sponsored by
Hillerod Hospital, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Major depression, relapse prevention, ECT, escitalopram, nortriptyline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mental Health Centre Copenhagen Department O

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Escitalopram 10 mg daily

Escitalopram 20 mg daily

escitalopram 30 mg daily

Nortriptylin 100 mg daily

Arm Description

Escitalopram 10 mg daily

Escitalopram 20 mg daily

escitalopram 30 mg daily

Nortriptylin 100 mg daily

Outcomes

Primary Outcome Measures

Hamilton depression rating scale

Secondary Outcome Measures

Drop out due to side-effects of drugs

Full Information

First Posted
April 14, 2008
Last Updated
December 7, 2014
Sponsor
Hillerod Hospital, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00660062
Brief Title
Relapse Prevention With Escitalopram or Nortriptyline Following Electro-Convulsive Treatment (DUAG-7)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Terminated
Why Stopped
Slow inclusion
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hillerod Hospital, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Major depression, relapse prevention, ECT, escitalopram, nortriptyline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram 10 mg daily
Arm Type
Experimental
Arm Description
Escitalopram 10 mg daily
Arm Title
Escitalopram 20 mg daily
Arm Type
Experimental
Arm Description
Escitalopram 20 mg daily
Arm Title
escitalopram 30 mg daily
Arm Type
Experimental
Arm Description
escitalopram 30 mg daily
Arm Title
Nortriptylin 100 mg daily
Arm Type
Active Comparator
Arm Description
Nortriptylin 100 mg daily
Intervention Type
Drug
Intervention Name(s)
escitalopram
Intervention Description
10 mg daily
Intervention Type
Drug
Intervention Name(s)
escitalopram
Intervention Description
20 mg daily dosage
Intervention Type
Drug
Intervention Name(s)
escitalopram
Intervention Description
30 mg daily dosage
Intervention Type
Drug
Intervention Name(s)
nortriptyline
Intervention Description
100 mg daily dosage
Primary Outcome Measure Information:
Title
Hamilton depression rating scale
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Drop out due to side-effects of drugs
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Martiny, MD,PhD
Organizational Affiliation
Mental Health Center Copenhagen Department O
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Centre Copenhagen Department O
City
Copenhagenl
ZIP/Postal Code
2100 Ø
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
11255384
Citation
Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307. doi: 10.1001/jama.285.10.1299.
Results Reference
background
PubMed Identifier
26529118
Citation
Martiny K, Larsen ER, Licht RW, Nielsen CT, Damkier P, Refsgaard E, Lunde M, Straaso B, Christensen EM, Lolk A, Holmskov J, Sorensen CH, Brodsgaard I, Eftekhari SZ, Bendsen BB, Klysner R, Terp IM, Larsen JK, Vestergaard P, Buchholtz PE, Gram LF, Bech P; Danish University Antidepressant Group (DUAG*). Relapse Prevention in Major Depressive Disorder After Successful Acute Electroconvulsive Treatment: a 6-month Double-blind Comparison of Three Fixed Dosages of Escitalopram and a Fixed Dose of Nortriptyline - Lessons from a Failed Randomised Trial of the Danish University Antidepressant Group (DUAG-7). Pharmacopsychiatry. 2015 Nov;48(7):274-8. doi: 10.1055/s-0035-1565063. Epub 2015 Nov 3.
Results Reference
derived
Links:
URL
http://www.duag.dk
Description
homepage for the DUAG organization

Learn more about this trial

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

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