Immune booster shows promise for bipolar depression
NCT ID NCT04133233
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a low dose of interleukin-2 (IL-2), a protein that helps regulate the immune system, could improve depressive symptoms in people with bipolar disorder. Fourteen participants already on mood stabilizers received the treatment. The goal was to see if it increased certain immune cells and eased depression.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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14 people
The number who actually took part.
- Started
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Jun 2020
- Finished
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May 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * A depressive episode according to DSM-V criteria in the course of a bipolar disorder * MADRS score \> 17 * Already on a mood stabilizer and/or antidepressant * Patient with a normal or controlled thyroid function * Male or female both using effective methods of contraception during treatment if sexually active. Exclusion Criteria: * \- Contraindication to IL-101 therapy: * Hypersensitivity to active substance or excipient; * Active infection requiring antibiotics therapy; * Organ failure (e.g., liver, kidney, lung and heart); * Immunosuppressed patient * Hepatotoxic, nephrotoxic, myelotoxic or cardiotoxic drugs * Other chronic diseases * Signs of active infection requiring treatment * Previous history of organ transplantation * Leukocytes \< 4000 / mm3, platelets \< 100 000 / mm3, Hemoglobin \< 10.0 g/dL or 6.2 mmol/L, red cell blood \< 3.5 T/L. * Anti-TPO or anti-TG or anti-TRACKS positive at inclusion. * Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder (NSAD, immunosuppressant IV-Ig based treatment); * Ongoing fever \< 38 * uncontrolled diabetes type I or II; * Existing cancer or history of cancer in the last 5 years (except skin epidermoid cancer or in-situ cervix cancer); * Existing or planned pregnancy or lactation; * Person under legal protection (1121-8 of CSP, Public Health Code * Pregnant and parturient and Breast feeding women (1121-5 of CSP) * legally detained person (1121-6 of CSP) * hospitalisation without consent * under the age of majority (1121-7of CSP) * Immediate risk for suicidal behaviour (MADRS-item 10 \>2 or columbia \> 2 for suicide idea); * Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS), Parkinson's or Alzheimer's disease, or any other serious condition likely to interfere with the conduct of the trial; * Participation to an interventional study concomitantly or within 30 days prior to this study, except in the cohorts studies aiming at the analysis of immuno-inflammatory biomarkers and/or brain imaging studies. * Patients thought to be unreliable or incapable of complying with the requirements of the protocol; * Patient is relative of, or staff directly reporting to the investigator; * Patient is employee of the sponsor.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pr Marion Leboyer
Créteil, Hôpital Albert Chenevier, 94010, France
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Other studies related to the condition(s) this trial covers.
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