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Triple-Blind Randomized Clinical Trial of Tocilizumab vs Placebo: Potential Use of an IL-6 Antagonist as an Adjuvant to Standard Treatment for Treatment-Resistant Major Depression in the Brazilian Public Health System (SUS)

ConditionTreatment-Resistant Major Depressive Disorder
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHospital de Clinicas de Porto Alegre

About this trial

Clinical trial aimed at evaluating whether a single infusion of tocilizumab, a medication that blocks the action of an inflammatory molecule called interleukin-6 (IL-6), can reduce symptoms of treatment-resistant major depression compared to placebo in non-hospitalized patients.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tocilizumab

    Biological/Vaccine

    Single infusion tocilizumab, 8 mg/kg, diluted in 100 mL of normal saline

  • Normal Saline (0.9% NaCl)

    Drug

    Placebo, same volume as intervention

Treatment groups

32 Participants
are divided into 3 treatment groups
Group A: TocilizumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Healthy controls, for comparison of inflammatory biomarkersNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Reduction in depressive symptoms (HDRS)

≥50% reduction in score

Time frame
Baseline and follow-ups (day 7, day 14, day 28 and month 6)

Secondary outcomes

1

Cognitive performance (Montreal Cognitive Test)

Time frame
Baseline and follow-ups (day 7, day 14, day 28 and month 6)
2

Quality of life (EUROHISQOL8)

Time frame
Baseline and follow-ups (day 7, day 14, day 28 and month 6)
3

BDNF levels

Serum Brain-Derived Neurotrophic Factor level

Time frame
Baseline and third follow-up post-intervention (28th day)
4

ECT indication after invervention

Time frame
Follow-ups (day 7, day 14, day 28 and month 6)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital de Clinicas de Porto Alegre

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: