| - candidate number | 0 |
| - NTR Number | NTR26 |
| - ISRCTN | ISRCTN36607067 |
| - Date ISRCTN created | 16-mei-2005 |
| - date ISRCTN requested | 12-apr-2005 |
| - Date Registered NTR | 23-dec-2004 |
| - Secondary IDs | N/A |
| - Public Title | Pharmacological treatment of psychotic depression. |
| - Scientific Title | Pharmacological treatment of psychotic depression. |
| - ACRONYM | DUDG (Dutch University Depression Group) |
| - hypothesis | Primary: 1. To compare in inpatients with psychotic depression the antidepressive efficacy at seven weeks of three treatment arms: [1] 7 weeks venlafaxine (maximum dose 375 mg); [2] 7 weeks imipramine (dose adjustment to adequate plasma levels of 200 ? 300 ug/L); [3] 7 weeks venlafaxine (maximum dose 375 mg) plus quetiapine (max. 600 mg/day); Secondary: 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 4 months in responders to treatment at 7 weeks. |
| - Healt Condition(s) or Problem(s) studied | Psychotic depression |
| - Inclusion criteria | 1. Age 18-65; 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) 18; 4. Written informed consent. |
| - Exclusion criteria | 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. - imipramine at least 4 weeks with adequate bloodlevels; - venlafaxine at least 4 weeks ? 300 mg dd; 4. Drug/alcohol dependence last 3 months; 5. Mental retardation (IQ <80); 6. Women: pregnancy or possibility for pregnancy and no adequate contraceptive measures. Breast-feeding; 7. Serious medical illness affecting CNS, e.g: M Parkinson, SLE, brain tumor, 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: antidepressives and/or antipsychotics other than study medication, steroids (prednison), mood stabilizers, 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’); 10. Direct ECT indication (e.g. very severe suicidality or refusal of food and drinking resulting in a life threatening situation); 11. MAO-I < 1 week before start of medication free period. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-mrt-2002 |
| - planned closingdate | 1-jul-2007 |
| - 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 ug/L). 3. Venlafaxine (maximum dose 375 mg) plus quetiapine (max. 600 mg/day). Duration of treatment: One week wash-out and 7 weeks acute treatment with venlafaxine or imipramine or venlafaxine plus quetiapine. Total: 8 weeks. |
| - Primary outcome | Proportion of responders. |
| - Secondary outcome | 1a. Change in HRSD scores; 1b. Change in CGI scores; 2. Time to response; 3. Adverse effects; 4. Group differences especially with regard to response to earlier treatments during current episode. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Dr. J. Wijkstra |
| - CONTACT for SCIENTIFIC QUERIES | Dr. J. Wijkstra |
| - Sponsor/Initiator | University Medical Center Utrecht (UMCU), University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care |
| - Funding (Source(s) of Monetary or Material Support) | AstraZeneca, Wyeth |
| - Publications | N/A |
| - Brief summary | Title: Pharmacological Treatment of Psychotic Depression. Objectives: Primary: 1. To compare in inpatients with psychotic depression the antidepressive efficacy at seven weeks of three treatment arms: [1] 7 weeks venlafaxine (maximum dose 375 mg); [2] 7 weeks imipramine (dose adjustment to adequate plasma levels of 200 ? 300 ug/L); [3] 7 weeks venlafaxine (maximum dose 375 mg) plus quetiapine (max. 600 mg/day). Secondary: 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 4 months in responders to treatment at 7 weeks. Type of patients: In-patients with psychotic depression. Number of patients: To include 180 patients (3 groups of 60 patients) 250 patients must be selected in 6 centres. Trial design: A double blind, randomised and stratified to the centres, multicentre study with a wash-out period, comparing 3 treatment strategies. Trial treatments: 1. Venlafaxine (maximum dose 375 mg); 2. Imipramine (dose adjustment to adequate plasma levels of 200 ? 300 ug/L); 3. Venlafaxine (maximum dose 375 mg) plus quetiapine (max. 600 mg/day). Duration of treatment: One week wash-out and 7 weeks acute treatment with venlafaxine or imipramine or venlafaxine plus quetiapine. Total: 8 weeks. Follow-up: Continuation treatment of responders during 4 months. Primary endpoints: 1. Proportion of responders. Secondary endpoints: 1a. Change in HRSD scores; 1b. Change in CGI scores; 2. Time to response; 3. Adverse effects; 4. Group differences especially with regard to response to earlier treatments during current episode. |
| - Main changes (audit trail) | |
| - RECORD | 5-jul-2005 - 9-dec-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl
- Dit zijn de gegevens waarmee uw trial is aangemeld en geregistreerd in het Nederlands Trial Register