Clinical trial NCT00660062: Relapse Prevention With Escitalopram or Nortriptyline Following Electro-Convulsive Treatment (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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Major Depression
Keywords: Major depression
relapse prevention
ECT
escitalopram
nortriptyline
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
First posted: 2008-04-17
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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

Primary outcomes:
measure: Hamilton depression rating scale
timeFrame: 14 days
Secondary outcomes:
measure: Drop out due to side-effects of drugs
timeFrame: 14 days
Other outcomes:
Locations:
city: Copenhagenl
country: Denmark
facility: Mental Health Centre Copenhagen Department O
Study officials:
affiliation: Mental Health Center Copenhagen Department O
name: Klaus Martiny, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.