Pharmacological treatment of Depression: Phase II Lithium addition.
- Conditions
- 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.
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 69
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in HRSD scores;<br>2. Change in CGI scores.<br>
- Secondary Outcome Measures
Name Time Method Adverse effects.