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Slow inclusion
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram 10 mg daily | Experimental | Escitalopram 10 mg daily |
|
| Escitalopram 20 mg daily | Experimental | Escitalopram 20 mg daily |
|
| escitalopram 30 mg daily | Experimental | escitalopram 30 mg daily |
|
| Nortriptylin 100 mg daily | Active Comparator | Nortriptylin 100 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| escitalopram | Drug | 10 mg daily |
| |
| escitalopram |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton depression rating scale | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Drop out due to side-effects of drugs | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Martiny, MD,PhD | Mental Health Center Copenhagen Department O | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Centre Copenhagen Department O | Copenhagenl | 2100 Ø | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11255384 | Background | 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. | |
| 26529118 | Derived |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D009661 | Nortriptyline |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Drug |
20 mg daily dosage |
|
| escitalopram | Drug | 30 mg daily dosage |
|
| nortriptyline | Drug | 100 mg daily dosage |
|
| 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. |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |