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23 May 2012
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| [ Print-friendly version ] |
| Pharmacological treatment of Depression: Phase II Lithium addition |
| ISRCTN | ISRCTN75768415 |
| ClinicalTrials.gov identifier | |
| Public title | Pharmacological treatment of Depression: Phase II Lithium addition |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | The two strategies (Venlafaxine and subsequent Lithium addition in non-responders to Venlafaxine; Imipramine and subsequent Lithium addition in non-responders to Imipramine) are comparable in efficacy and time to response. |
| Lay summary | |
| Ethics approval | Ethics approval received from the local medical ethics committee |
| Study design | A double blind, randomized single-centre study with a washout period, comparing 2 treatment strategies. |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Depression |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/06/2005 |
| Anticipated end date | 01/06/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 69 |
| Interventions |
Venlafaxine (maximum dose 375 mg) and subsequent Lithium addition; Imipramine (dose adjustment to adequate plasma levels of 200-300 µg/l) and subsequent Lithium addition. |
| Primary outcome measure(s) |
1. Change in HRSD scores 2. Change in CGI scores |
| Secondary outcome measure(s) | Adverse effects. |
| Sources of funding | Wyeth |
| Trial website | |
| Publications | |
| Contact name | Dr W.W. Broek, van den |
| Address |
Erasmus Medical Center Department of Psychiatry P.O. Box 2040 |
| City/town | Rotterdam |
| Zip/Postcode | 3000 CA |
| Country | Netherlands |
| w.w.vandenbroek@erasmusmc.nl | |
| Sponsor | Erasmus Medical Center (The Netherlands) |
| Address | P.O. Box 2040 |
| City/town | Rotterdam |
| Zip/Postcode | 3000 CA |
| Country | Netherlands |
| Date applied | 28/04/2006 |
| Last edited | 28/04/2006 |
| Date ISRCTN assigned | 28/04/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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