Treatment-resistant depression in the elderly

Completed

Conditions: Depression
Mental and Behavioural Disorders
1. Depressive episode2. Recurrent depressive disorder

Registration Number: ISRCTN93105957

Lead Sponsor: Altrecht Mental Health Care (Altrecht Geestelijke Gezondheidszorg [GGZ]) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Male or female inpatient
2. Aged 60 years or older
3. Meet the Diagnostic and Statistical Manual of Mental Disorders (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 Montgomery-Asberg Depression Rating Scale (MADRS)
6. Have a Mini Mental State Examination (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 MonoAmine Oxide (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 seriously 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