Major Depression | Relapse Prevention With Escitalopram or Nortriptyline Following Electro-Convulsive Treatment (DUAG-7)
Major Depression research study
What is the primary objective of this study?
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).
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:escitalopram10 mg daily
Drug:escitalopram20 mg daily dosage
Drug:escitalopram30 mg daily dosage
Drug:nortriptyline100 mg daily dosage
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Escitalopram 10 mg dailyEscitalopram 10 mg daily
Escitalopram 20 mg dailyEscitalopram 20 mg daily
escitalopram 30 mg dailyescitalopram 30 mg daily
Nortriptylin 100 mg dailyNortriptylin 100 mg daily
Start Date: August 2009
Completed Date: November 2014
Phase: Phase 4
Primary Outcome: Hamilton depression rating scale
Secondary Outcome: Drop out due to side-effects of drugs
Study sponsors, principal investigator, and references
Principal Investigator: Klaus Martiny, MD,PhD
Lead Sponsor: Hillerod Hospital, Denmark
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.