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
Secondary identifying numbers	NTR27

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

Altrecht GGZ
Jutfaseweg 205
Utrecht
3522 HR
Netherlands

Phone	+31 (0)30 2297600
Email	r.kok@altrecht.nl

Study information

Study design	Randomised, double blind, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Venlafaxine, nortriptyline
Primary outcome measure	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 study start date	01/10/1999
Completion date	01/12/2004

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	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

Sponsor information

Altrecht GGZ (The Netherlands)
Industry

Jutfaseweg 205
Utrecht
3522 HR
Netherlands

Website	http://www.altrecht.nl/
"ROR"	https://ror.org/050jqep38

Funders

Funder type

Industry

Wyeth Pharmaceuticals B.V. (The Netherlands) (ref: 100186)

No information available

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	01/12/2007		Yes	No