Major depression.
Conditions
Interventions
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
Sponsors
ZON-MW
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: remission defined as a final score of 10 or less on the MADRS. Tolerability: Global Tolerability Score. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Public ContactRob M. Kok
Altrecht GGZ Jutfaseweg 205
Outcome results
None listed