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21 May 2012
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| [ Print-friendly version ] |
| Pharmacological treatment of psychotic depression |
| ISRCTN | ISRCTN36607067 |
| ClinicalTrials.gov identifier | |
| Public title | Pharmacological treatment of psychotic depression |
| Scientific title | |
| Acronym | DUDG (Dutch University Depression Group) |
| Serial number at source | NTR26 |
| Study hypothesis |
Primary hypothesis:
To compare in in-patients with psychotic depression the anti-depressive efficacy at seven weeks of three treatment arms: 1. Seven weeks venlafaxine (maximum dose 375 mg) 2. Seven weeks imipramine (dose adjustment to adequate plasma levels of 200 - 300 µg/l) 3. Seven weeks venlafaxine (maximum dose 375 mg) plus quetiapine (maximum 600 mg/day) Secondary hypotheses: 1. To compare in patients with psychotic depression the tolerability of venlafaxine, imipramine and venlafaxine plus quetiapine 2. To find factors modifying treatment efficacy, such as response to earlier treatments during current episode 3. To evaluate efficacy and tolerability of continuation treatment during four months in responders to treatment at seven weeks |
| Lay summary | |
| Ethics approval | Ethics approval received from the local medical ethics committee |
| Study design | Randomised, double-blind, active-controlled, parallel, multi-centre trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | In-patients with psychotic depression |
| Participants - inclusion criteria |
1. Aged 18 - 65 years
2. Major depressive disorder, single or recurrent episode, with psychotic features (Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM-IV]) 3. Hamilton Rating Scale for Depression (HRSD) (17 item) 4. Written informed consent |
| Participants - exclusion criteria |
Any of the following is regarded as a criterion for exclusion from the trial:
1. Bipolar I or II disorder 2. Schizophrenia or other primary psychotic disorder 3. Treatment of current episode with adequate trial of imipramine or venlafaxine: 3.1. Imipramine at least four weeks with adequate blood levels 3.2. Venlafaxine at least four weeks 300 mg dd 4. Drug/alcohol dependence in the last three months 5. Mental retardation (intelligent quotient [IQ] less than 80) 6. Women: 6.1. Pregnancy or possibility for pregnancy and no adequate contraceptive measures 6.2. Breast-feeding 7. Serious medical illness affecting central nervous system (CNS) e.g. Parkinson's Disease, systemic lupus erythematosus (SLE), brain tumour, cerebrovascular accident (CVA) 8. Relevant medical illness as contra-indications for the use of study medication, such as recent myocardial infarction 9. Medication affecting CNS, e.g. anti-depressives and/or anti-psychotics other than study medication, steroids (prednisone), mood stabilisers, benzodiazepines (if not being tapered): greater than 3 mg lorazepam (or equivalent) 10. Direct electroconvulsive therapy (ECT) indication (e.g. very severe suicidality or refusal of food and drinking resulting in a life threatening situation) 11. Monoamine oxidase inhibitor (MAO-I) less than one week before start of medication free period |
| Anticipated start date | 01/03/2002 |
| Anticipated end date | 01/07/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 160 |
| Interventions |
Trial treatments:
1. Venlafaxine (maximum dose 375 mg) 2. Imipramine (dose adjustment to adequate plasma levels of 200 - 300 µg/l) 3. Venlafaxine (maximum dose 375 mg) plus quetiapine (max 600 mg/day) Duration of treatment: one week wash-out and seven weeks acute treatment with venlafaxine or imipramine or venlafaxine plus quetiapine. Total: eight weeks. |
| Primary outcome measure(s) | Proportion of responders. |
| Secondary outcome measure(s) |
1. Change in:
1.1. HRSD scores 1.2. Clinical Global Impressions (CGI) scale 2. Time to response 3. Adverse effects 4. Group differences, especially with regard to response to earlier treatments during current episode |
| Sources of funding |
1. Wyeth Pharmaceuticals B.V. (The Netherlands)
2. AstraZeneca (The Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Dr J. Wijkstra |
| Address |
University Medical Center Utrecht (UMCU)
B01.206, Department of Psychiatry P.O. Box 85500 |
| City/town | Utrecht |
| Zip/Postcode | 3508 GA |
| Country | Netherlands |
| Tel | +31 (0)30 250 8178 |
| J.Wijkstra@azu.nl | |
| Sponsor | University Medical Center Utrecht (UMCU) (The Netherlands) |
| Address |
Julius Center for Health Sciences and Primary Care
P.O. Box 85500 |
| City/town | Utrecht |
| Zip/Postcode | 3508 GA |
| Country | Netherlands |
| Tel | +31 (0)30 2509358 |
| Fax | +31 (0)30 505480 |
| juliuscenter@azu.nl | |
| Sponsor website: | http://www.umcutrecht.nl/zorg/ |
| Date applied | 16/05/2005 |
| Last edited | 02/04/2008 |
| Date ISRCTN assigned | 16/05/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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