Contact information
Type
Scientific
Primary contact
Dr J. Wijkstra
ORCID ID
Contact details
University Medical Center Utrecht (UMCU)
B01.206
Department of Psychiatry
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 8178
J.Wijkstra@azu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR26
Study information
Scientific title
Acronym
DUDG (Dutch University Depression Group)
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
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, double-blind, active-controlled, parallel, multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
In-patients with psychotic depression
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Venlafaxine, imipramine, quetiapine
Primary outcome measures
Proportion of responders.
Secondary outcome measures
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
Overall trial start date
01/03/2002
Overall trial end date
01/07/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant 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
Recruitment start date
01/03/2002
Recruitment end date
01/07/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht (UMCU)
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
University Medical Center Utrecht (UMCU) (The Netherlands)
Sponsor details
Julius Center for Health Sciences and Primary Care
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2509358
juliuscenter@azu.nl
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Wyeth Pharmaceuticals B.V. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
AstraZeneca (The Netherlands)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary