OSU6162 in Bipolar Depression: An Open-label, Flexible Dose Study (OBID)
An explorative, open label, single armed, flexible dose, single center, phase IIa study of 8 weeks, initiated in subjects with bipolar depression. The study will consist of 9 visits and 1 safety visit. Subjects with a primary diagnosis of bipolar disorder (type 1 or 2) currently in an acute depressive phase (i.e. bipolar depression) and being on stable medication with at least one mood stabilizer.
• Signed informed consent
• Voluntary admission to the psychiatric ward prior or directly after the screening point
• Age: 18-65 on the day of screening
• Meeting DSM-5 criteria for a depressive episode in Bipolar Disorder type I or type II, as confirmed by the Mini International Neuropsychiatric Interview (MINI)
• Displaying a sum score of ≥10 on the Bech 6-item subscale of the Hamilton Depression rating Scale.
• Treatment with a stable dose of a mood stabilizer since at least 4 weeks before screening: lithium s-conc\> 0,45 mmol/L; \>lamotrigine dose 100 mg/d; \>valproate dose \> 900 mg/d, \>carbamazepine concentration \>20 mmol/L
• In female patients of childbearing potential: negative result of a pregnancy test and a method of contraception with a failure rate of less than 1 %. Women of childbearing potential must, for inclusion, use a highly efficient method of contraception, i.e. a method with a failure rate of less than 1% (e.g. sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomy in partner).
• Male patients must agree to use condoms during the study and for 2 weeks after the end of the study/last dose of IMP, unless their partner is using a highly efficient method of contraception, as described above.