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.