Pharmacological treatment of psychotic depression

ISRCTN	ISRCTN36607067
DOI	https://doi.org/10.1186/ISRCTN36607067
Secondary identifying numbers	NTR26

Submission date: 16/05/2005
Registration date: 16/05/2005
Last edited: 02/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J. Wijkstra
Scientific

University Medical Center Utrecht (UMCU)
B01.206, Department of Psychiatry
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone	+31 (0)30 250 8178
Email	J.Wijkstra@azu.nl

Study information

Study design	Randomised, double-blind, active-controlled, parallel, multi-centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	DUDG (Dutch University Depression Group)
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Venlafaxine, imipramine, quetiapine
Primary outcome measure	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 study start date	01/03/2002
Completion date	01/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	160
Key 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
Key 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
Date of first enrolment	01/03/2002
Date of final enrolment	01/07/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Utrecht (UMCU)

Utrecht
3508 GA
Netherlands

Sponsor information

University Medical Center Utrecht (UMCU) (The Netherlands)
University/education

Julius Center for Health Sciences and Primary Care
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone	+31 (0)30 2509358
Email	juliuscenter@azu.nl
Website	http://www.umcutrecht.nl/zorg/
"ROR"	https://ror.org/0575yy874

Funders

Funder type

Industry

Wyeth Pharmaceuticals B.V. (The Netherlands)

No information available

AstraZeneca (The Netherlands)
Government organisation / For-profit companies (industry)

Alternative name(s): AstraZeneca PLC, Pearl Therapeutics
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan