The purpose of this study will be to demonstrate improvement of the T regulatory cells (Treg) response, under add on low-dose Interleukin 2 (ld-IL2) in patients with bipolar disorders experiencing a depressive relapse
A hypothesis still under study concerning the pathophysiological mechanisms of bipolar disorder concerns an immunological disorder that could possibly be involved in this disease and during a depressive episode. In particular, that the multiplication of a certain category of white blood cells called "regulators" that block the toxic effect of more aggressive white blood cells could improve these disorders. The aim of this research is therefore to check the effectiveness and safety of injections of Interleukin 2 (IL-2) to induce this multiplication of regulatory white blood cells. IL-2 is a natural protein released by white blood cells that is used for the proper functioning of the immune defence system. The favourable effects of injecting small doses of IL-2 are known and assessed in other diseases, including autoimmune diseases. The secondary objective of this study is to assess the effect of these injections on patient's mood, which could be improved by this treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
Treatment administration consists in a first course of five-day treatment (induction), followed by a single injection every week for 4 weeks (maintenance; from Week 3 to Week 6)
Treatment administration consists in a first course of five-day treatment (induction), followed by a single injection every week for 4 weeks (maintenance; from Week 3 to Week 6)
Pr Marion Leboyer
Créteil, Hôpital Albert Chenevier, France
change of Treg response
Percentage Treg fold increase compared to baseline at Day 5
Time frame: baseline to Day 5
Treg response, under ld-IL2 in relation with symptomatic assessment of mood improvements
Change in the value of Montgomery Asberg Depression Rating and in The inventory of depressive symptomatology
Time frame: from baseline to week 6
changes in immune homeostasis under ld-IL2 in relation with symptomatic assessment of mood improvements
variation in Treg /CD4+ at different visit expressed as percentage of baseline value
Time frame: between Day 5 and Day 60
Assess the incidence of ld-IL2(safety and tolerability) in patients with a depressive episode in the course of a bipolar disorder
Frequency and type of adverse events during the trial.
Time frame: baseline to Day 60
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