RecruitingPhase 2NCT05296356

OSU6162 in Bipolar Depression (OBID)

OSU6162 in Bipolar Depression: An Open-label, Flexible Dose Study (OBID)

Sponsor

Göteborg University

Enrollment

22 participants

Start Date

Oct 25, 2021

Study Type

INTERVENTIONAL

Conditions

Bipolar Depression

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called OSU6162 can reduce depression symptoms in people diagnosed with bipolar disorder who are currently experiencing a depressive episode and are already taking a mood stabilizer. **You may be eligible if...** - You are between 18 and 65 years old - You are currently admitted (or recently admitted) to a psychiatric ward - You meet diagnostic criteria for a depressive episode in bipolar disorder type I or II - You have been on a stable dose of a mood stabilizer (such as lithium, lamotrigine, valproate, or carbamazepine) for at least 4 weeks - Your depression is at a clinically significant level on a standardized rating scale **You may NOT be eligible if...** - You are not currently on a mood stabilizer - You are pregnant or could become pregnant without using contraception - You have serious physical illness or unstable medical conditions - You have significant risk of drug interactions with OSU6162 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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