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Immune booster shows promise for bipolar depression

NCT ID NCT04133233

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

14 people

The number who actually took part.

Started

Jun 2020

Finished

May 2022

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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

  • Pr Marion Leboyer

    Créteil, Hôpital Albert Chenevier, 94010, France

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