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

Completed

• Conditions: Mental and Behavioural Disorders; Depression; Depressive disorders

• Registration Number: ISRCTN23246262
• Lead Sponsor: Altrecht GGZ (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 81

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission on the MADRS (final score of 10 or less).

Secondary Outcome Measures

Name	Time	Method
1. Remission on Hamilton Depression rating scale (HAM-D) and Geriatric Depression Scale (GDS)<br>2. Response on MADRS, HAM-D and GDS<br>3. Number of side effects<br>4. Global Tolerability Score<br>5. MMSE<br>6. Barthel Activities of Daily Living (ADL) score<br>7. 20-item Short Form health survey (SF-20)