ISRCTN - ISRCTN36607067: Pharmacological treatment of psychotic depression

Plain English Summary

Not provided at time of registration

Trial website

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 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 trial start date

01/03/2002

Overall trial end date

01/07/2007

Reason abandoned (if study stopped)

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