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A randomised, double-blind, parallel-group comparison of the efficacy and the safety of venlafaxine versus nortriptyline in the treatment of depressed elderly inpatients.


- candidate number0
- NTR NumberNTR27
- ISRCTNISRCTN23246262
- Date ISRCTN created16-mei-2005
- date ISRCTN requested12-apr-2005
- Date Registered NTR26-jan-2005
- Secondary IDsN/A 
- Public TitleA randomised, double-blind, parallel-group comparison of the efficacy and the safety of venlafaxine versus nortriptyline in the treatment of depressed elderly inpatients.
- Scientific TitleA randomised, double-blind, parallel-group comparison of the efficacy and the safety of venlafaxine versus nortriptyline in the treatment of depressed elderly inpatients.
- ACRONYMN/A
- hypothesisVenlafaxine and nortriptyline are not significant different in efficacy in elderly inpatients with depression but venlafaxine is better tolerated.
- Healt Condition(s) or Problem(s) studiedDepression
- Inclusion criteria1. Male or female inpatient;
2. Aged 60 years or older;
3. Meet the DSM-IV criteria for major depression, single or recurrent episode (296.2x, 296.3x), dysthymic disorder (300.4), mood disorder due to a general medical condition, with depressive features or with major depressive -like episode (293.83), substance induced mood disorder with depressive features (292.84), depressive disorder not otherwise specified (i.e. minor depressive disorder) (311);
4. Have a baseline MADRS total score ? 20;
5. Have a baseline MMSE score > 15;
6. Written informed consent.
- Exclusion criteria1. Known hypersensivity to venlafaxine or nortriptyline;
2. Previous unsuccessful treatment with venlafaxine for at least 4 weeks with a minimum dose of 75 mg/day or previous unsuccessful treatment with nortriptyline for at least 4 weeks with a serum level within the therapeutic range;
3. Relevant medical illness which is a contra-indication for the use of the study medication, such as myocardial infarction within previous 6 months;
4. Use of electroconvulsive therapy (ECT) within 30 days prior to baseline, use of a MAO inhibitor within 14 days, use of fluoxetine within 21 days, use of any antidepressant drug (except those allowed during the study as concomitant treatment) within 3 days prior to baseline;
5. Alcohol or drug abuse within the last year, according to DSM IV criteria;
6. Presence of dementia, or a non-affective psychotic disorder, or a history of bipolar disorder (I and II), all according to DSM-IV criteria.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-1999
- planned closingdate1-dec-2004
- Target number of participants81
- InterventionsNortriptyline (range 25-200 mg) or venlafaxine (range 75-300 mg).
- Primary outcomeRemission on the MADRS (final score of 10 or less).
- Secondary outcomeRemission on HAM-D and GDS, response on MADRS, HAM-D and GDS, number of side effects, Global Tolerability Score, MMSE, Barthel ADL score, SF-20.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. Rob M. Kok
- CONTACT for SCIENTIFIC QUERIESDr. Rob M. Kok
- Sponsor/Initiator Altrecht GGZ
- Funding
(Source(s) of Monetary or Material Support)
Wyeth
- Publications1. Int J Geriatr Psychiatry. 2007 Dec;22(12):1247-54.
- Brief summaryMost trials on pharmacological treatment of major depression in the elderly are outpatient trials, which mostly included relatively young, physically healthy, moderate depressed patients. As a result of this, data are lacking on the treatment of the most severe and difficult-to-treat forms of depression in the elderly. In this 'real- world' trial, depressed inpatients with moderate-severe depression and, most often many physicall illnesses, are included and treated with either venlafaxine or nortriptyline.
- Main changes (audit trail)
- RECORD5-jul-2005 - 23-jun-2008


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