Condition category
Mental and Behavioural Disorders
Date applied
16/05/2005
Date assigned
16/05/2005
Last edited
02/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.altrecht.nl/

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

  1. 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.

Additional files

Editorial Notes