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
Recruitment status was Recruiting
Sponsor:
Hillerod Hospital, Denmark
Information provided by:
Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT00660062
First received: April 14, 2008
Last updated: April 29, 2011
Last verified: April 2011
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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:
MedlinePlus related topics:
Depression
Drug Information available for:
Nortriptyline
Nortriptyline hydrochloride
Citalopram hydrobromide
Citalopram
Escitalopram oxalate
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 |
|---|---|
|
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 May 16, 2013