A double-blind, and randomized singlecenter trial comparing two treatment strategies in patients with a major depression. During phase I patients were treated during 7 weeks with: Imipramine or Venlafaxine. In phase II the non-responders of phase I will be treated with Lithium addition in an open trial during 4 weeks. During these 4 weeks the antidepressant drugs from phase I will be continued at the same dose under maintaining double-blind conditions.
Conditions
Interventions
1. Venlafaxine (maximum dose 375 mg) and subsequent Lithium addition
2. Imipramine (dose adjustment to adequate plasma levels of 200-300 mug/l) and subsequent Lithium addition.
Sponsors
none
Eligibility
Inclusion criteria
Inclusion criteria: All non-responders in phase I In phase 1 inclusion criteria were: 1. Age 18-65; 2. Major depressive disorder, single or recurrent episode (DSM-IV); 3. HRSD (17 item) larger than or equal to 14; 4. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients whom are incapable to understand the information and to give informed consent. And patients whom 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 last 3 months; 7. Mental retardation (IQ smaller than 80); 8. Women: pregnancy or possibility for pregnancy and no adequate contraceptive measures. Breastfeeding; 9. Serious medical illness affecting CNS, e.g.: M. Parkinson, SLE, brain tumor, 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: see appendix ‘Moleman P. 1998. Praktische psychofarmacologie. Derde druk. Bohn Stafleu Van Loghum. Page 19’); 12. Direct 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): a. Kidney failure; b. Acute myocard infarct; c. Myasthenia gravis; d. Breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in HRSD scores; 2. Change in CGI scores. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects. | — |
Contacts
Public ContactW.W. Broek, van den
Erasmus Medical Center, Department of Psychiatry, P.O. Box 2040
Outcome results
None listed