Actively Recruiting
OSU6162 in Bipolar Depression (OBID)
Led by Göteborg University · Updated on 2025-03-21
22
Participants Needed
1
Research Sites
292 weeks
Total Duration
On this page
Sponsors
G
Göteborg University
Lead Sponsor
A
Arvid Carlsson Research AB
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OSU6162 in Bipolar Depression (OBID)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Voluntary admission to the psychiatric ward prior or directly after screening
- Age between 18 and 65 years at screening
- Diagnosis of depressive episode in Bipolar Disorder type I or II confirmed by MINI
- Bech 6-item subscale score of 10 or higher on Hamilton Depression rating Scale
- Stable dose of mood stabilizer for at least 4 weeks before screening (lithium >0.45 mmol/L, lamotrigine ≥100 mg/d, valproate >900 mg/d, or carbamazepine >20 mmol/L)
- For women of childbearing potential: negative pregnancy test and use of highly effective contraception with failure rate <1%
- For male patients: agreement to use condoms during and for 2 weeks after study unless partner uses highly effective contraception
You will not qualify if you...
- Ongoing compulsory care
- Imminent risk of suicide or harm to self, others, or property
- Diagnosis of obsessive-compulsive disorder or post-traumatic stress disorder
- Previous diagnosis of personality disorder, autism, ADHD, or intellectual disability
- History of substance or alcohol abuse within 2 years prior to screening
- Other CNS disorders making participation unsuitable (e.g., dementia, brain injury, epilepsy)
- Young Mania Rating Scale score above 12 at screening or during trial
- Somatic illness or symptoms making participation unsafe
- Abnormal vital signs, labs, or ECG including QTc exceeding 450 ms (men) or 460 ms (women)
- Factors likely to reduce compliance with treatment or visits
- Medication changes or dosage changes within 4 weeks prior to screening or during trial
- Treatment with potent cytochrome P450 enzyme inhibitors
- Treatment with drugs with narrow therapeutic window except lithium
- Treatment with drugs affecting dopaminergic synapses (e.g., antipsychotics, bupropion, stimulants, Parkinson's drugs)
- No observed beneficial effect of treatment making participation unethical
- Previous use of OSU6162
- Current participation in another clinical trial
- Nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sahlgrenska university hospital/Östra
Gothenburg, Sweden, SE 405 30
Actively Recruiting
Research Team
E
Elias Eriksson, Professor
CONTACT
S
Steinn Steingrimsson, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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