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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21203

Enrollment

Registered

2006-11-06

Start date

2006-11-21

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

One intravenous administration of infliximab 3mg/kg or placebo

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

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. MMSE </- 22/30; 10. Insufficient knowledge of the Dutch language.

Design outcomes

Primary

Measure	Time frame
Severity of depression according to the Montgomery-Asberg Depression Rating Scale, 8 weeks after infliximab infusion.	—

Secondary

Measure	Time frame
1. 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.	—

Measure

Time frame

1. 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.

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Contacts

Public ContactD.W. Maas

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

d.w.maas@lumc.nl+31 (0)71 5263785

Outcome results