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

Major Depression Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00660062
• Other study ID #: DUAG-7
• Status: Terminated
• Phase: Phase 4
• First received: April 14, 2008
• Last updated: December 7, 2014
• Start date: August 2009
• Est. completion date: November 2014

Study information

• Verified date: April 2011
• Source: Hillerod Hospital, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depression

Intervention

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

Locations

Country	Name	City	State
Denmark	Mental Health Centre Copenhagen Department O	Copenhagenl

Sponsors (1)

Lead Sponsor	Collaborator
Hillerod Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton depression rating scale		14 days	No
Secondary	Drop out due to side-effects of drugs		14 days	Yes

External Links

•   homepage for the DUAG organization