Both active medications are equally effective in the treatment of non-responding elderly patients but phenelzine is better tolerated than lithium.
ID
Bron
Verkorte titel
Aandoening
Major depression.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Efficacy: remission defined as a final score of 10 or less on the MADRS. <br>
Tolerability: Global Tolerability Score.<br>
Achtergrond van het onderzoek
A 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.
Doel van het onderzoek
Both active medications are equally effective in the treatment of non-responding elderly patients but phenelzine is better tolerated than lithium.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Patients 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.
Publiek
Jutfaseweg 205
Rob M. Kok
Jutfaseweg 205
Utrecht 3522 HR
The Netherlands
+31 (0)30 2297600
r.kok@altrecht.nl
Wetenschappelijk
Jutfaseweg 205
Rob M. Kok
Jutfaseweg 205
Utrecht 3522 HR
The Netherlands
+31 (0)30 2297600
r.kok@altrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL413 |
NTR-old | NTR453 |
Ander register | : 1360.0001 |
ISRCTN | ISRCTN93105957 |