Condition category
Mental and Behavioural Disorders
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
29/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D W Maas

ORCID ID

Contact details

Leiden University Medical Center (LUMC)
Department of Psychiatry
B1-P
P.O. Box 750
Leiden
2300 RC
Netherlands
+31 (0)71 526 3785
d.w.maas@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PO4.061

Study information

Scientific title

Acronym

Study hypothesis

Aetiology of late-onset depressive spectrum disorders may be different from the aetiology of early-onset depression. Concordant with the supposed aetiology of dementia, it has been postulated that chronic low grade immune activation plays a role in the aetiology of late-onset depressive spectrum disorders.

Also, administration of a Tumor Necrotising Factor (TNF)-alfa antagonist in psoriasis was associated with increased wellbeing and decreased depressive symptoms, independent of improvement of the psoriasis.

Therefore, we think that administration of the TNF-alpha antagonist infliximab may be effective in the treatment of late-onset depressive spectrum disorders.

The aim of this study is to determine the effectiveness of infliximab compared to placebo in the treatment of late-onset, antidepressant resistant (one antidepressant) depressive spectrum disorders in patients of 60 years and above.

Ethics approval

Approval received from the Medical Ethics Committee on the 22nd August 2006 (ref: P04.61).

Study design

Randomised, placebo controlled, parallel group, double blinded, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Depressive disorders

Intervention

One intravenous administration of infliximab 3 mg/kg or placebo.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Severity of depression according to the Montgomery-Asberg Depression Rating Scale, eight weeks after infliximab infusion.

Secondary outcome measures

1. Presence and severity of apathy, eight weeks after infliximab infusion
2. Change in plasmaconcentration of C-Reactive Protein (CRP), from baseline till eight weeks after infliximab infusion
3. Association of LipoPolySaccharide (LPS) induced production capacity at baseline and outcome of depression, eight weeks after infliximab infusion
4. Association of circadian cortisol rhythm at baseline and outcome of depression, eight weeks after infliximab infusion

Overall trial start date

21/11/2006

Overall trial end date

30/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with depressive spectrum disorders (dysthymia, minor and major depression) using Standardised Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Fourth edition (DSM-IV) disorders
2. Age more than 60 years
3. Late onset of depressive spectrum disorder (age more than 55 years)
4. Resistant to at least one regular antidepressant drug, used for at least six weeks and in sufficient doses; or suffering from too many side effects of the antidepressant

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

50

Participant 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. Mini Mental State Examination (MMSE) less than or equal to 22/30
10. Insufficient knowledge of the Dutch language

Recruitment start date

21/11/2006

Recruitment end date

30/11/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Center (LUMC) (The Netherlands)

Sponsor details

Department of Psychiatry
P.O. Box 750
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/english/start_english.html#http://www.lumc.nl/english/start_english.html

Funders

Funder type

Hospital/treatment centre

Funder name

Leiden University Medical Center (LUMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Beekman AT, Geerlings SW, Deeg DJ, et al. The natural history of late life depression: a 6-year prospective study study in the community. Arch Gen Psychiatry 2002, 59; 605-11.
- Biggelaar AHJ van den, Gussekloo J, Stek ML, Craen AMJ de, Frohlich M, Mast RC van der, Westendorp RGJ. Inflammation and the interleukin-1-signaling pathway contribute to depressive symptoms, but not cognitive decline in old age. Submitted for publication.
- Heun R, Kockler M, Papassotiropoulos A. Distinction of early- and late-onset depression in the elderly by their lifetime symptomatology. Int J Geriatr Psychiatry. 2000;15:1138-1142.
- Lyness JM, Moonseong H, Datto CJ, et al. Outcomes of minor and subsyndromal depression among elderly patients in primary care settings. Ann Int Med 2006; 144:496-504.
- Penninx BW, Kritchevsky SB, Yaffe K, Newman AB, Simonsick EM, Rubin S, et al. Inflammatory markers and depressed mood in older persons: results from the Health, Aging and Body Composition study. Biol Psychiatry 2003; 54:566-572.
- Rowe SK & Hyman Rapaport H. Classification and treatment of sub-treshold depression. Curr Opin Psychiatry 2006; 19:199-213.
- Stek M.L. et al. Prevalence, correlates and recognition of depression in the oldest old: the Leiden 85-plus study. J Affect Disord. 2004;78:193-200.
- Stek M.L., Vinkers D.J., Gussekloo J., Mast R.C. van der, Beekman A.T.F. & Westendorp R.G.J. The natural history of depression in the oldest old. A population-based prospective study. Brit J Psychiatry 2006; 188:65-69.
- Tiemeier H, Hofman A, van Tuijl HR, Kiliaan AJ, Meijer J, Breteler MM (2003): Inflammatory proteins and depression in the elderly. Epidemiology 2003;14:103-107.

Publication citations

Additional files

Editorial Notes