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

NCT ID: NCT00660062

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Major Depression

Keywords

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Major depression relapse prevention ECT escitalopram nortriptyline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Escitalopram 10 mg daily

Escitalopram 10 mg daily

Group Type EXPERIMENTAL

escitalopram

Intervention Type DRUG

10 mg daily

Escitalopram 20 mg daily

Escitalopram 20 mg daily

Group Type EXPERIMENTAL

escitalopram

Intervention Type DRUG

20 mg daily dosage

escitalopram 30 mg daily

escitalopram 30 mg daily

Group Type EXPERIMENTAL

escitalopram

Intervention Type DRUG

30 mg daily dosage

Nortriptylin 100 mg daily

Nortriptylin 100 mg daily

Group Type ACTIVE_COMPARATOR

nortriptyline

Intervention Type DRUG

100 mg daily dosage

Interventions

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escitalopram

10 mg daily

Intervention Type DRUG

escitalopram

20 mg daily dosage

Intervention Type DRUG

escitalopram

30 mg daily dosage

Intervention Type DRUG

nortriptyline

100 mg daily dosage

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillerod Hospital, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Klaus Martiny

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Martiny, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Mental Health Center Copenhagen Department O

Locations

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Mental Health Centre Copenhagen Department O

Copenhagenl, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 11255384 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26529118 (View on PubMed)

Related Links

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http://www.duag.dk

homepage for the DUAG organization

Other Identifiers

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DUAG-7

Identifier Type: -

Identifier Source: org_study_id