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A randomised, double-blind, parallel-group comparison of the efficacy and the safety of venlafaxine versus nortriptyline in the treatment of depressed elderly inpatients.

A randomised, double-blind, parallel-group comparison of the efficacy and the safety of venlafaxine versus nortriptyline in the treatment of depressed elderly inpatients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27258
Enrollment
81
Registered
2005-01-26
Start date
1999-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Nortriptyline (range 25-200 mg) or venlafaxine (range 75-300 mg).

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female inpatient; 2. Aged 60 years or older; 3. Meet the DSM-IV criteria for major depression, single or recurrent episode (296.2x, 296.3x), dysthymic disorder (300.4), mood disorder due to a general medical condition, with depressive features or with major depressive -like episode (293.83), substance induced mood disorder with depressive features (292.84), depressive disorder not otherwise specified (i.e. minor depressive disorder) (311); 4. Have a baseline MADRS total score ? 20; 5. Have a baseline MMSE score > 15; 6. Written informed consent.

Exclusion criteria

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 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.

Design outcomes

Primary

MeasureTime frame
Remission on the MADRS (final score of 10 or less).

Secondary

MeasureTime frame
Remission on HAM-D and GDS, response on MADRS, HAM-D and GDS, number of side effects, Global Tolerability Score, MMSE, Barthel ADL score, SF-20.

Contacts

Public ContactRob M. Kok

Altrecht GGZ Jutfaseweg 205

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)