No registrations found.
ID
Source
Brief title
Health condition
Major depression.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy: remission defined as a final score of 10 or less on the MADRS.
Tolerability: Global Tolerability Score.
Secondary outcome
Response 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).
Background summary
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.
Study objective
Both active medications are equally effective in the treatment of non-responding elderly patients but phenelzine is better tolerated than lithium.
Study design
N/A
Intervention
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.
Jutfaseweg 205
Rob M. Kok
Jutfaseweg 205
Utrecht 3522 HR
The Netherlands
+31 (0)30 2297600
r.kok@altrecht.nl
Jutfaseweg 205
Rob M. Kok
Jutfaseweg 205
Utrecht 3522 HR
The Netherlands
+31 (0)30 2297600
r.kok@altrecht.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL413 |
| NTR-old | NTR453 |
| Other | : 1360.0001 |
| ISRCTN | ISRCTN93105957 |