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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR802 |
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Date of registration:
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06/11/2006 |
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Primary sponsor: |
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Public title:
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Effectiveness of infliximab (TNF-alpha antagonist) in the treatment of late-onset depressive spectrum disorder in patients of 60 years and above.
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Scientific title:
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Effectiveness of infliximab (TNF-alpha antagonist) in the treatment of late-onset, depressive spectrum disorder in patients of 60 years and above. - N/A |
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Date of first enrolment:
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21/11/2006 |
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Target sample size:
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50 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=802 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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D.W.
Maas |
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Address:
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Leiden University Medical Center (LUMC), Department of Psychiatry, B1-P,
P.O. Box 750
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5263785 |
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Email:
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d.w.maas@lumc.nl |
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Affiliation:
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Name:
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R.C.
Mast, van der |
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Address:
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Leiden University Medical Center (LUMC), Department of Psychiatry, B1-P,
P.O. Box 750
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5263785 |
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Email:
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r.c.van_der_mast@lumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with depressive spectrum disorders (dysthymia, minor and major depression) using Standardised Clinical Interview for DSM-IV disorders;
2. Age > 60 years;
3. Late onset of depressive spectrum disorder (age > 55 years);
4. Resistant to at least 1 regular antidepressant drug, used for at least 6 weeks and in sufficient doses; or suffering from too many side effects of the antidepressant.
Exclusion criteria: 1. Psychotic features;
2. Bipolar disorder;
3. Severe suicidal thoughts or actions;
4. Serious infectious diseases;
5. (Suspicion of) tuberculosis;
6. Serious cardiac failure;
7. Prior treatment with recombinant antibodies;
8. Allergy to infliximab;
9. MMSE 10. Insufficient knowledge of the Dutch language.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Depressive disorders
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Intervention(s)
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One intravenous administration of infliximab 3mg/kg or placebo
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Primary Outcome(s)
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Severity of depression according to the Montgomery-Asberg Depression Rating Scale, 8 weeks after infliximab infusion.
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Secondary Outcome(s)
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1. Presence and severity of apathy, 8 weeks after infliximab infusion;
2. Change in plasmaconcentration of CRP, from baseline till 8 weeks after infliximab infusion;
3. Association of LPS induced production capacity at baseline and outcome of depression, 8 weeks after infliximab infusion;
4. Association of circadian cortisol rhythm at baseline and outcome of depression, 8 weeks after infliximab infusion.
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Secondary ID(s)
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ISRCTN65900535
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PO4.061
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Source(s) of Monetary Support
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Leiden University Medical Center (LUMC), Department of Psychiatry
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