Relapse Prevention With Escitalopram or Nortriptyline Following Electro-Convulsive Treatment (DUAG-7)
Information source: Hillerod Hospital, Denmark
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression
Intervention: escitalopram (Drug); escitalopram (Drug); escitalopram (Drug); nortriptyline (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Hillerod Hospital, Denmark Overall contact:
Klaus Martiny, Ph.D., Phone: 45-4829-3237, Email: kmar@noh.regionh.dk
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).
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Hamilton depression rating scale
Secondary outcome: Drop out due to side-effects of drugs
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Klaus Martiny, Ph.D., Phone: 45-4829-3237, Email: kmar@noh.regionh.dk Additional Information
homepage for the DUAG organization
Related publications: 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.
Starting date: November 2008
Ending date: May 2012
Last updated: April 16, 2008
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