OSU6162 in Bipolar Depression (OBID)

NCT ID: NCT05296356

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2027-05-31

Brief 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.

Conditions

Bipolar Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OSU6162

Coated tablet, flexible dosing

Group Type: EXPERIMENTAL

OSU6162

Intervention Type: DRUG

OSU6162

Interventions

OSU6162

OSU6162

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arvid Carlsson Research AB

INDUSTRY

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sahlgrenska university hospital/Östra

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Elias Eriksson, Professor

Role: CONTACT

elias.eriksson@neuro.gu.se

+ 46 709 555055

Steinn Steingrimsson, MD, PhD

Role: CONTACT

steinn.steingrimsson@vgregion.se

+ 46 722 448372

Facility Contacts

Michael Ioannou, MD

Role: primary

michael.ioannou@vgregion.se

+46 70 082 38 20

Other Identifiers

2024-517560-30-00

Identifier Type: CTIS

Identifier Source: secondary_id

2020-001980-95

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EudraCT number: 2020-001980-95

Identifier Type: -

Identifier Source: org_study_id