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

Sponsor:	Hillerod Hospital, Denmark
Information provided by:	Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:	NCT00660062

Purpose

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).

Condition	Intervention	Phase
Major Depression	Drug: escitalopram Drug: nortriptyline	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Nortriptyline Escitalopram Escitalopram oxalate Nortriptyline hydrochloride

U.S. FDA Resources

Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:

Hamilton depression rating scale [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Drop out due to side-effects of drugs [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	240
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: escitalopram 10 mg daily Drug: escitalopram 20 mg daily dosage Drug: escitalopram 30 mg daily dosage Drug: nortriptyline 100 mg daily dosage
B: Experimental	Drug: escitalopram 20 mg daily dosage Drug: escitalopram 30 mg daily dosage Drug: nortriptyline 100 mg daily dosage
C: Experimental	Drug: escitalopram 30 mg daily dosage Drug: nortriptyline 100 mg daily dosage
D: Active Comparator	Drug: nortriptyline 100 mg daily dosage

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660062

Contacts

Contact: Klaus Martiny, Ph.D.	45-4829-3237	kmar@noh.regionh.dk
Contact: Else Refsgaard	45-4829-3237	elre@noh.regionh.dk

Locations

Denmark
Psychiatric Research Unit, Hillerod Hospital	Recruiting
Frederiksborg General Hospital, Denmark, 3400
Contact: Klaus Martiny, MD Ph.D. +45 4829 3315 kmar@fa.dk
Contact: Per Bech, Professor +45 4829 3253 pebe@fa.dk
Principal Investigator: Klaus Martiny, MD Ph.D.
Sub-Investigator: Marianne Lunde, Coordinator

Sponsors and Collaborators

Hillerod Hospital, Denmark

More Information

Additional Information:

homepage for the DUAG organization This link exits the ClinicalTrials.gov site

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.

Responsible Party:	Psychiatric Research Unit, Frederiksborg General Hospital, Denmark ( Klaus Martiny )
Study ID Numbers:	DUAG-7
Study First Received:	April 14, 2008
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00660062 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Hillerod Hospital, Denmark:

Major depression
relapse prevention
ECT
escitalopram
nortriptyline

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Disease Attributes
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Adrenergic Uptake Inhibitors
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Pathologic Processes

Mental Disorders
Therapeutic Uses
Nortriptyline
Antidepressive Agents, Second-Generation
Dexetimide
Antidepressive Agents
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Recurrence
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Behavioral Symptoms
Muscarinic Antagonists

ClinicalTrials.gov processed this record on November 05, 2009