OSU6162 in Bipolar Depression (OBID)

NCT ID
NCT05296356
Registry status
Recruiting
Study type
Not specified in the registry data
Phase
Phase 2
Sponsor
Göteborg University

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 22 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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 International Neuropsychiatric Interview (MINI) 5. Displaying a sum score of ≥10 on the Bech 6-item subscale of the Hamilton Depression rating Scale. 6. 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 7. 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). 8. 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. Exclusion Criteria: 1. Ongoing compulsory care. 2. Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. 3. Previously diagnosed or meeting MINI criteria at interview for obsessive-compulsive disorder or post-traumatic stress disorder. 4. A previous diagnosis of a personality disorder, autism, ADHD, or intellectual disability. 5. A history of substance/alcohol abuse within 2 years prior to screening. 6. Any other previously diagnosed or suspected CNS disorder that according to the investigator renders the patient unsuitable for participation in the trial (such as dementia, brain injury, and epilepsy). 7. Young Mania Rating Scale (YMRS) total score of \>12 at screening or at any time during the trial. 8. Any somatic illness that according to the investigator renders the patient unsuitable for participation in the trial. 9. Any signs or symptoms of somatic illness resulting from assessment of vital signs, physical examination, clinical laboratory tests or 12- lead ECG that according to the investigator renders the patient unsuitable for participation for safety reasons, including a QTc-time on ECG exceeding 450 ms in men and 460 ms in women. 10. Any factor that according to the investigator renders it unlikely that the patient will comply with the instructions regarding treatment, visits etc. 11. Any change in medication (including dosage) of an antidepressant drug or a mood stabiliser within 4 weeks prior to screening or at any time during the trial. 12. Ongoing treatment with potent cytochrome P450 enzyme inhibitors (e.g., bupropion, fluvoxamin, ketoconazol, itraconazole, telitromycin, clarithromycin, protease inhibitors, quinidine, and terbinafine). 13. Ongoing treatment with drugs displaying a narrow therapeutic window - with the exception of lithium - where either reduced or increased serum levels are potentially harmful (including but not limited to warfarin, other anticoagulants, digoxin. other antiarrythmics, anticonvulsants when prescribed for treatment of epilepsy but not when prescribed for bipolar disorder, cyclosporine, and immunosuppressants). 14. Ongoing treatment with drugs with dopaminergic synapses as primary site of action (e.g., antipsychotics, bupropion, central stimulants, and drugs for Parkinson's disease). 15. No observed beneficial effect of treatment and a symptom severity that by the investigator's assessment would render continued participation unethical. 16. Previous intake of OSU6162. 17. Current participation in another clinical trial. 18. Nursing women.

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Sweden

Sample of listed locations

  • Sahlgrenska university hospital/Östra — Gothenburg, SE 405 30, Sweden — Site recruitment status not specified in the registry data

Study details

Start date
October 25, 2021
Primary completion date
May 31, 2029
First posted
March 25, 2022

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT05296356
Registry last updated
September 15, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT05296356 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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