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Pharmacological treatment of Depression: Phase II Lithium addition.


- candidate number2024
- NTR NumberNTR633
- ISRCTNISRCTN75768415
- Date ISRCTN created28-apr-2006
- date ISRCTN requested25-apr-2006
- Date Registered NTR20-mrt-2006
- Secondary IDsN/A 
- Public TitlePharmacological treatment of Depression: Phase II Lithium addition.
- Scientific TitleA double blind, randomized singlecentre study with a washout period, comparing 2 treatment strategies.
- ACRONYMN/A
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedDepression
- Inclusion criteriaAll 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jun-2005
- planned closingdate1-jun-2009
- Target number of participants69
- Interventions1. 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.
- Primary outcome1. Change in HRSD scores; 2. Change in CGI scores.
- Secondary outcomeAdverse effects.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. W.W. Broek, van den
- CONTACT for SCIENTIFIC QUERIESMD. PhD. W.W. Broek, van den
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Wyeth
- PublicationsN/A
- Brief summaryTITLE Pharmacological treatment of Depression: Phase II Lithium addition OBJECTIVES PRIMARY: To compare in inpatients with a depression the antidepressive efficacy at 11 weeks of two treatment arms: (1) 7 weeks Venlafaxine (maximum dose 375 mg) and subsequent 4 weeks Lithium addition in the non-responders to Venlafaxine; (2) 7 weeks Imipramine (dose adjustment to adequate plasma levels of 200-300 mug/day) and subsequent 4 weeks Lithium addition in the non-responders to Imipramine. SECONDARY: To compare in patients with a depression the tolerability of Lithium Evaluate efficacy and tolerability during continuation of 4 months of treatment in the responders TYPE OF PATIENTS: Non-responders to the treatment of phase I NUMBER OF PATIENTS: The expectation is that 50 % will respond in phase I, the 50 % non-responders will be included in phase II. The study starts with 138 patients; thus we expect 69 patients can be included in phase II. TRIAL DESIGN: An open addition of Lithium to non-responders of phase I: patients with a depression who were randomized and received double-blind Imipramine or Venlafaxine. TRIAL TREATMENTS: 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 DURATION OF TREATMENT: 4 weeks, with al least 3 weeks lithium with adequate plasma levels FOLLOW-UP: Continuation treatment of responders during 4 months PRIMARY ENDPOINTS: Proportion of responders Change in: 1. HRSD scores 2. CGI scores. SECONDARY ENDPOINTS: Adverse effects.
- Main changes (audit trail)
- RECORD20-mrt-2006 - 16-jun-2006


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