| April 14, 2008 |
| August 4, 2009 |
| August 2009 |
| August 2012 (final data collection date for primary outcome measure) |
| Hamilton depression rating scale [ Time Frame: 14 days ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00660062 on ClinicalTrials.gov Archive Site |
| Drop out due to side-effects of drugs [ Time Frame: 14 days ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Relapse Prevention With Escitalopram or Nortriptyline Following Electro-Convulsive Treatment (DUAG-7) |
| 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 |
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). |
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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Major Depression |
- Drug: escitalopram
- Drug: nortriptyline
|
| |
| 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. |
| |
| Recruiting |
| 240 |
| August 2012 |
| August 2012 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
|
|
| Denmark |
| |
| NCT00660062 |
| Klaus Martiny, Psychiatric Research Unit, Frederiksborg General Hospital, Denmark |
| DUAG-7 |
| Hillerod Hospital, Denmark |
|
|
| Hillerod Hospital, Denmark |
| August 2009 |