Contact information
Type
Scientific
Primary contact
Dr Rob M. Kok
ORCID ID
Contact details
Altrecht GGZ
Jutfaseweg 205
Utrecht
3522 HR
Netherlands
+31 (0)30 2297600
r.kok@altrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR27
Study information
Scientific title
Acronym
Study hypothesis
Venlafaxine and nortriptyline are not significantly different in efficacy in elderly inpatients with depression but venlafaxine is better tolerated.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, double blind, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Depressive disorders
Intervention
1. Nortriptyline (range 25 - 200 mg)
2. Venlafaxine (range 75 - 300 mg)
Intervention type
Drug
Phase
Not Specified
Drug names
Venlafaxine, nortriptyline
Primary outcome measures
Remission on the MADRS (final score of 10 or less).
Secondary outcome measures
1. Remission on Hamilton Depression rating scale (HAM-D) and Geriatric Depression Scale (GDS)
2. Response on MADRS, HAM-D and GDS
3. Number of side effects
4. Global Tolerability Score
5. MMSE
6. Barthel Activities of Daily Living (ADL) score
7. 20-item Short Form health survey (SF-20)
Overall trial start date
01/10/1999
Overall trial end date
01/12/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
81
Participant 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
Recruitment start date
01/10/1999
Recruitment end date
01/12/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
Altrecht GGZ
Utrecht
3522 HR
Netherlands
Sponsor information
Organisation
Altrecht GGZ (The Netherlands)
Sponsor details
Jutfaseweg 205
Utrecht
3522 HR
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Wyeth Pharmaceuticals B.V. (The Netherlands) (ref: 100186)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/17562523
Publication citations
-
Results
Kok RM, Nolen WA, Heeren TJ, Venlafaxine versus nortriptyline in the treatment of elderly depressed inpatients: a randomised, double-blind, controlled trial., Int J Geriatr Psychiatry, 2007, 22, 12, 1247-1254, doi: 10.1002/gps.1823.