A randomised, double-blind, parallel-group comparison of the efficacy and the safety of venlafaxine versus nortriptyline in the treatment of depressed elderly inpatients
| ISRCTN | ISRCTN23246262 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23246262 |
| Protocol serial number | NTR27 |
| Sponsor | Altrecht GGZ (The Netherlands) |
| Funder | Wyeth Pharmaceuticals B.V. (The Netherlands) (ref: 100186) |
- Submission date
- 16/05/2005
- Registration date
- 16/05/2005
- Last edited
- 02/04/2008
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blind, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Venlafaxine and nortriptyline are not significantly different in efficacy in elderly inpatients with depression but venlafaxine is better tolerated. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Depressive disorders |
| Intervention | 1. Nortriptyline (range 25 - 200 mg) 2. Venlafaxine (range 75 - 300 mg) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Venlafaxine, nortriptyline |
| Primary outcome measure(s) |
Remission on the MADRS (final score of 10 or less). |
| Key secondary outcome measure(s) |
1. Remission on Hamilton Depression rating scale (HAM-D) and Geriatric Depression Scale (GDS) |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 81 |
| Key inclusion criteria | 1. Male or female inpatient 2. Aged 60 years or older 3. Meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for: 3.1. Major depression, single or recurrent episode (296.2x, 296.3x) 3.2. Dysthymic disorder (300.4) 3.3. Mood disorder due to a general medical condition, with depressive features or with major depressive-like episode (293.83) 3.4. Substance induced mood disorder with depressive features (292.84) 3.5. Depressive disorder not otherwise specified (i.e. minor depressive disorder) (311) 4. Have a baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to 20 5. Have a baseline Mini-Mental State Examination (MMSE) score greater than 15 6. Written informed consent |
| Key exclusion criteria | 1. Known hypersensivity to venlafaxine or nortriptyline 2. Previous unsuccessful treatment with venlafaxine for at least 4 weeks with a minimum dose of 75 mg/day or previous unsuccessful treatment with nortriptyline for at least 4 weeks with a serum level within the therapeutic range 3. Relevant medical illness which is a contra-indication for the use of the study medication, such as myocardial infarction within previous 6 months 4. Use of electroconvulsive therapy (ECT) within 30 days prior to baseline, use of a monoamine oxidase (MAO) inhibitor within 14 days, use of fluoxetine within 21 days, use of any antidepressant drug (except those allowed during the study as concomitant treatment) within 3 days prior to baseline 5. Alcohol or drug abuse within the last year, according to DSM-IV criteria 6. Presence of dementia, or a non-affective psychotic disorder, or a history of bipolar disorder (I and II), all according to DSM-IV criteria |
| Date of first enrolment | 01/10/1999 |
| Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Altrecht GGZ
Utrecht
3522 HR
Netherlands
3522 HR
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/12/2007 | Yes | No |
