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…
ID
Bron
Verkorte titel
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Severity of depression according to the Montgomery-Asberg Depression Rating Scale, 8 weeks after infliximab infusion.
Achtergrond van het onderzoek
Background: 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 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.
Aim of this study: to determine the effectiveness of infliximab compared to placebo in the treatment of late-onset (first depressive episode above the age of 55 years), antidepressant resistant (one antidepressant) depressive spectrum disorders in patients of 60 years and above. Moreover, we want to investigate the effects of 1. LPS induced production capacity of cytokines in whole blood at baseline and 2. saliva cortisol concentrations at baseline, on outcome. Further, we will look into the influence of infliximab on presence and severity of apathy, and CRP plasmaconcentrations.
Design of the study: randomized placebo controlled double-blind study.
Methods: The Structured Clinical Interview for DSM-IV-TR (SCID) is used to confirm late-onset depressive spectrum disorder. Patients with bipolar disorder, psychotic features, severe suicidal thoughts or actions, severe cognitive impairment (MMSE<22/30), infection, tuberculosis and cardiac failure will be excluded. Patients are randomized into two groups, one receiving infliximab 3mg/kg intravenously (n=25), the other receiving placebo intravenously (n=25). Primary outcome is the effect on depressive symptoms 8 weeks after infusion, as assessed with the Montgomery-Asberg Depression Rating Scale (MADRS). Apathy is measured using Starkstein’s Apathy Scale. Follow-up is done during 24 weeks.
Doel van het onderzoek
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 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.
Onderzoeksproduct en/of interventie
One intravenous administration of infliximab 3mg/kg or placebo
Publiek
P.O. Box 750
D.W. Maas
Leiden 2300 RC
The Netherlands
+31 (0)71 5263785
d.w.maas@lumc.nl
Wetenschappelijk
P.O. Box 750
D.W. Maas
Leiden 2300 RC
The Netherlands
+31 (0)71 5263785
d.w.maas@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL790 |
| NTR-old | NTR802 |
| Ander register | : PO4.061 |
| ISRCTN | ISRCTN65900535 |
Samenvatting resultaten
- 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.