Treatment-resistant depression in the elderly
| ISRCTN | ISRCTN93105957 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93105957 |
| Secondary identifying numbers | NTR453; 1360.0001 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 17/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rob M. Kok
Scientific
Scientific
Altrecht GGZ
Jutfaseweg 205
Utrecht
3522 HR
Netherlands
| Phone | +31 (0)30 2297600 |
|---|---|
| r.kok@altrecht.nl |
Study information
| Study design | Randomised single blind active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Both active medications are equally effective in the treatment of non-responding elderly patients but phenelzine is better tolerated than lithium. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Depression |
| Intervention | Patients start with either phenelzine 15 mg or lithiumcarbonate 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Phenelzine, lithiumcarbonate |
| Primary outcome measure | Efficacy: remission defined as a final score of 10 or less on the MADRS. Tolerability: Global Tolerability Score. |
| Secondary outcome measures | 1. Response defined as a reduction of at least 50% of MADRS, Hamilton Depression Scale (HAM-D) and Geriatric Depression Scale (GDS), Clinical Global Impression (CGI) 1-2 2. Remission on HAM-D, GDS 3. Number of (serious) side effects and drop out rate due to the study medication 4. MMSE-score, Trail Making Test (TMT), Dutch Verbal Learning and Memory Test (Verbale Leer en Geheugen Test [VLGT]) (cognitive tests) |
| Overall study start date | 01/01/2000 |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Altrecht GGZ
Utrecht
3522 HR
Netherlands
3522 HR
Netherlands
Sponsor information
Altrecht Mental Health Care (Altrecht Geestelijke Gezondheidszorg [GGZ]) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Jutfaseweg 205
Utrecht
3522 HR
Netherlands
"ROR" |
https://ror.org/050jqep38 |
|---|
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Parke Davis (USA)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Parke Davis & Company
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2007 | Yes | No |
