Relapse Prevention With Escitalopram or Nortriptyline Following Electro-Convulsive Treatment (DUAG-7)
Information source: Hillerod Hospital, Denmark
ClinicalTrials.gov processed this data on August 23, 2015 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: Terminated
Sponsored by: Hillerod Hospital, Denmark Official(s) and/or principal investigator(s): Klaus Martiny, MD,PhD, Principal Investigator, Affiliation: Mental Health Center Copenhagen Department O
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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
Mental Health Centre Copenhagen Department O, Copenhagenl 2100 Ø, Denmark
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: August 2009
Last updated: December 7, 2014
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