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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Hillerod Hospital, Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT00660062
First received: April 14, 2008
Last updated: April 29, 2011
Last verified: April 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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
Experimental: Escitalopram 10 mg daily
Escitalopram 10 mg daily
Drug: escitalopram
10 mg daily
Experimental: Escitalopram 20 mg daily
Escitalopram 20 mg daily
Drug: escitalopram
20 mg daily dosage
Experimental: escitalopram 30 mg daily
escitalopram 30 mg daily
Drug: escitalopram
30 mg daily dosage
Active Comparator: Nortriptylin 100 mg daily
Nortriptylin 100 mg daily
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
Mental Health Centre Copenhagen Department O Recruiting
Copenhagenl, Denmark, 2100 Ø
Contact: Klaus Martiny, MD Ph.D.    +45 4829 3315    klaus.martiny@regionh.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
Investigators
Principal Investigator: Klaus Martiny, MD,PhD Mental Health Center Copenhagen Department O
  More Information

Additional Information:
Publications:
Responsible Party: Klaus Martiny, Psychiatric Research Unit, Frederiksborg General Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00660062     History of Changes
Other Study ID Numbers: DUAG-7
Study First Received: April 14, 2008
Last Updated: April 29, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Hillerod Hospital, Denmark:
Major depression
relapse prevention
ECT
escitalopram
nortriptyline

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Nortriptyline
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Adrenergic Uptake Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014