Pharmacological treatment of Depression: Phase II Lithium additio

Completed

• Conditions: Depression; Mental and Behavioural Disorders

• Registration Number: ISRCTN75768415
• Lead Sponsor: Erasmus Medical Center (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

All non-responders in phase I.
In phase I inclusion criteria were:
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) greater than or equal to 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):
a. Kidney failure
b. Acute myocardial infarction
c. Myasthenia gravis
d. Breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified