Effectiveness of infliximab (tumor necrotising factor-alpha antagonist) in the treatment of late-onset depressive spectrum disorder in patients of 60 years and above

ISRCTN	ISRCTN65900535
DOI	https://doi.org/10.1186/ISRCTN65900535
Protocol serial number	PO4.061, NL790, NTR802
Sponsor	Leiden University Medical Center (LUMC) (The Netherlands)
Funder	Leiden University Medical Center (LUMC) (The Netherlands)

Submission date: 28/12/2006
Registration date: 28/12/2006
Last edited: 05/08/2021

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr D W Maas
Scientific

Leiden University Medical Center (LUMC)
Department of Psychiatry, B1-P
P.O. Box 750
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 526 3785
Email	d.w.maas@lumc.nl

Study information

Primary study design	Interventional
Study design	Randomised, placebo controlled, parallel group, double blinded, multicentre trial
Secondary study design	Randomised controlled trial
Scientific title	Effectiveness of infliximab (tumor necrotising factor-alpha antagonist) in the treatment of late-onset depressive spectrum disorder in patients of 60 years and above
Study objectives	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(s)	Approval received from the Medical Ethics Committee on the 22nd August 2006 (ref: P04.61).
Health condition(s) or problem(s) studied	Depressive disorders
Intervention	One intravenous administration of infliximab 3 mg/kg or placebo.
Intervention type	Other
Primary outcome measure(s)	Severity of depression according to the Montgomery-Asberg Depression Rating Scale, eight weeks after infliximab infusion.
Key secondary outcome measure(s)	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
Completion date	30/11/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	21/11/2006
Date of final enrolment	30/11/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center (LUMC)

Leiden
2300 RC
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/06/2010	05/08/2021	Yes	No

Editorial Notes

05/08/2021: The following changes have been made:
1. Publication reference added.
2. The NTR numbers have been added.