Pharmacological treatment of depressio

Not Applicable

Completed

• Conditions: Depression; Mental and Behavioural Disorders

• Registration Number: ISRCTN73221288
• Lead Sponsor: Erasmus Medical Center (The Netherlands)

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28478653

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-28
• Study Completion: 2008-01-01
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

For inclusion in the trial, patients must fulfill all of the following criteria:
1. Age 18-65
2. Major depressive disorder, single or recurrent episode (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV])
3. Hamilton Rating Scale for Depression (HRSD) (17 item) >/= 14
4. Written informed consent

Exclusion Criteria

Any of the following is regarded as a criterion for exclusion from the trial:
1. Patients who are incapable of understanding the information and of giving informed consent. Also, patients who are unable to read or write
2. Major depression with psychotic features (separate study)
3. Bipolar I or II disorder
4. Schizophrenia or other primary psychotic disorder
5. Treatment of current episode with adequate trial of Imipramine or Venlafaxine
6. Drug/alcohol dependence in the last 3 months
7. Mental retardation (IQ <80)
8. Women: pregnancy or possibility for pregnancy and no adequate contraceptive measures. Breastfeeding.
9. Serious medical illness affecting central nervous system (CNS) e.g. M. Parkinson, systemic lupus erythematosus (SLE), brain tumor, cerebrovascular accident (CVA)
10. Relevant medical illness as contra-indications for the use of study medication (Venlafaxine and Imipramine), such as recent myocardial infarction and severe liver or kidney failure
11. Medication affecting CNS e.g. antidepressants and/or antipsychotics other than study medication, steroids (prednison), mood stabilisers, benzodiazepines (if not being tapered): >3 mg lorazepam (or equivalent)
12. Direct electroconvulsive therapy (ECT) indication (e.g. very severely suicidal or refusal of food and drinking resulting in life threatening situation)
13. Contra-indications for Lithium (Moleman, 1998):
13.1. Kidney failure
13.2. Acute myocardial infarction
13.3. Myasthenia gravis
13.4. Breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified