OSU6162 in Bipolar Depression (OBID)
Recruiting
Phase 2
Interventional Study
Bipolar Depression
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 22 (estimated)
- Sponsor
- Göteborg University · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Signed informed consent
2. Voluntary admission to the psychiatric ward prior or directly after the screening point
3. Age: 18-65 on the day of screening
4. Meeting DSM-5 criteria for a depressive episode in Bipolar Disorder type I or type II, as confirmed by the Mini Internat…
Contacts