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van CCT (UK)

van CCT (UK)

Treatment-resistent depression in the elderly.

- candidate number1750
- NTR NumberNTR453
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR13-okt-2005
- Secondary IDs1360.0001 
- Public TitleTreatment-resistent depression in the elderly.
- Scientific TitleA randomised, open, single-blind parallel-group comparison of the efficacy and the tolerability of phenelzine versus antidepressant augmentation with lithium in the treatment of non-responding depressed elderly inpatients.
- hypothesisBoth active medications are equally effective in the treatment of non-responding elderly patients but phenelzine is better tolerated than lithium.
- 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);
4. Non-response to adequate treatment with a tricyclic antidepressant (minimal 4-6 weeks with serum levels within therapeutic window) or venlafaxine (minimal 4-6 weeks with a sum serum level of venlafaxine+ O-desmethylvenlafaxine > 200 microgram);
5. Have a baseline total score of at least 20 on the MADRS;
6. Have a MMSE score > 15;
7. In the opinion of the investigator, have sufficient intelligence and motivation to comply with, and is competent to understand, the study procedures (especially dietary instructions in case of phenelzine);
8. Sign the written informed consent.
- Exclusion criteria1. Known hypersensitivity to lithium or phenelzine;
2. Previous unsuccessful adequate (minimal 15 mg during 4 weeks) treatment with phenelzine or with lithiumaugmentation (minimal serum level of 0.6 mmol/l during 4 weeks);
3. Use of lithium or phenelzine within 30 days prior to baseline, use of a MAO inhibitor within 14 days, use of fluoxetine within 21 days, use of any other psychotropic drug (except antidepressants and those allowed during the study as concomitant treatment) within 7 days prior to baseline;
4. The presence of a physical illness which serious interacts with treatment with either lithium or phenelzine;
5. Alcohol or drug abuse within the last 2 years, according to DSM IV criteria;
6. Presence of dementia or non-affective psychotic disorder, history of bipolar disorder (I and II);
7. Concomitant use of alcohol or drugs that can have serious interactions with phenelzine or lithium.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2000
- planned closingdate1-jan-2005
- Target number of participants30
- InterventionsPatients start with either phenelzine 15 mg or lithiumcabonate 200 mg. The dose will be increased with phenelzine 15 mg or lithiumcarbonate 200 mg after 4-8 days. The minimum daily dose of phenelzine is 15 mg and the maximum daily dose is 60 mg. Lithium is dosed to reach a serum level between 0.6 - 0.8 mmol/l.
- Primary outcomeEfficacy: remission defined as a final score of 10 or less on the MADRS.
Tolerability: Global Tolerability Score.
- Secondary outcomeResponse defined as a reduction of at least 50 % of MADRS, HAM-D and GDS, CGI 1-2. Remission on HAM-D, GDS. Number of (serious) side effects and drop out rate due to the study medication. MMSE-score, TMT, VLGT (cognitive tests).
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Altrecht GGZ
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Parke Davis
- Publications1. J Clin Psychiatry. 2007 Aug;68(8):1177-85.
- Brief summaryA minority of 20-40% of elderly depressed patients fails to respond to pharmacological treatment. These patients may be treated in a number of different ways, but randomised controlled trials in the elderly are not available. Two often used strategies in treatment-resistant depressed elderly in the Netherlands are augmentation with lithium and an irreversible MAO inhibitor. Both will be compared in a randomised, single-blind study design.
- Main changes (audit trail)
- RECORD13-okt-2005 - 23-jun-2008

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