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


- candidate number2309
- NTR NumberNTR802
- ISRCTNISRCTN65900535
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR6-nov-2006
- Secondary IDsPO4.061 
- Public TitleEffectiveness of infliximab (TNF-alpha antagonist) in the treatment of late-onset depressive spectrum disorder in patients of 60 years and above.
- Scientific TitleEffectiveness of infliximab (TNF-alpha antagonist) in the treatment of late-onset, depressive spectrum disorder in patients of 60 years and above.
- ACRONYMN/A
- hypothesisAetiology 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.
- Healt Condition(s) or Problem(s) studiedDepressive disorders
- Inclusion criteria1. 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.
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 21-nov-2006
- planned closingdate1-aug-2008
- Target number of participants50
- InterventionsOne intravenous administration of infliximab 3mg/kg or placebo
- Primary outcomeSeverity of depression according to the Montgomery-Asberg Depression Rating Scale, 8 weeks after infliximab infusion.
- Secondary outcome1. Presence and severity of apathy, 8 weeks after infliximab infusion; 2. Change in plasmaconcentration of CRP, from baseline till 8 weeks after infliximab infusion; 3. Association of LPS induced production capacity at baseline and outcome of depression, 8 weeks after infliximab infusion; 4. Association of circadian cortisol rhythm at baseline and outcome of depression, 8 weeks after infliximab infusion.
- Timepoints
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. D.W. Maas
- CONTACT for SCIENTIFIC QUERIESMD., PhD R.C. Mast, van der
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Psychiatry
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Department of Psychiatry
- Publications- 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.
- Brief summaryBackground: 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.
- Main changes (audit trail)
- RECORD6-nov-2006 - 5-jan-2009


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