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 |
| Secondary identifying numbers | PO4.061, NL790, NTR802 |
- 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
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 |
|---|---|
| d.w.maas@lumc.nl |
Study information
| Study design | Randomised, placebo controlled, parallel group, double blinded, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 21/11/2006 |
| Completion date | 30/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 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
2300 RC
Netherlands
Sponsor information
Leiden University Medical Center (LUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Psychiatry
P.O. Box 750
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/english/start_english.html#http://www.lumc.nl/english/start_english.html |
|---|---|
"ROR" |
https://ror.org/05xvt9f17 |
Funders
Funder type
Hospital/treatment centre
Leiden University Medical Center (LUMC) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
