Bipolar DepressionPhase 2OBIDNCT05296356
OSU6162 in Bipolar Depression (OBID)
A Phase 2 study testing OSU6162 in people with Bipolar Depression, run by Göteborg University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- OSU6162
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSweden
- Study dates
- 25 Oct 2021to 31 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Voluntary admission to the psychiatric ward prior or directly after the screening point
- Age: 18-65 on the day of screening
- 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)
- Displaying a sum score of ≥10 on the Bech 6-item subscale of the Hamilton Depression rating Scale.
- 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
- 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).
- 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.
Who cannot join
- Ongoing compulsory care.
- Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- Previously diagnosed or meeting MINI criteria at interview for obsessive-compulsive disorder or post-traumatic stress disorder.
- A previous diagnosis of a personality disorder, autism, ADHD, or intellectual disability.
- A history of substance/alcohol abuse within 2 years prior to screening.
- 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).
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- Young Mania Rating Scale (YMRS) total score of >12 at screening or at any time during the trial.
- Any somatic illness that according to the investigator renders the patient unsuitable for participation in the trial.
- 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.
- Any factor that according to the investigator renders it unlikely that the patient will comply with the instructions regarding treatment, visits etc.
- 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.
- Ongoing treatment with potent cytochrome P450 enzyme inhibitors (e.g., bupropion, fluvoxamin, ketoconazol, itraconazole, telitromycin, clarithromycin, protease inhibitors, quinidine, and terbinafine).
- 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).
- Ongoing treatment with drugs with dopaminergic synapses as primary site of action (e.g., antipsychotics, bupropion, central stimulants, and drugs for Parkinson's disease).
- No observed beneficial effect of treatment and a symptom severity that by the investigator's assessment would render continued participation unethical.
- Previous intake of OSU6162.
- Current participation in another clinical trial.
- Nursing women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska university hospital/Östra
Gothenburg, SE 405 30
Michael Ioannou, MD, +46 70 082 38 20, michael.ioannou@vgregion.se
About this study
Official title: OSU6162 in Bipolar Depression: An Open-label, Flexible Dose Study (OBID)
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
- Being tested
- OSU6162
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSU6162Drug
OSU6162
| Study group | Role | What they receive |
|---|---|---|
| OSU6162 | Experimental | Coated tablet, flexible dosing Receives: Drug: OSU6162 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) at endpoint [Day 60].
Measured: Endpoint at 60 days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start25 Oct 2021
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open study
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Arvid Carlsson Research AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296356
- Sponsor's protocol ID
- EudraCT number: 2020-001980-95
- Other IDs
- 2024-517560-30-00, 2020-001980-95
- Acronym
- OBID
- Status last verified
- Jun 2026
- First submitted
- 8 Nov 2021
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSU6162 in Bipolar Depression: An Open-label, Flexible Dose Study (OBID)
- ClinicalTrials.gov ID
- NCT05296356
- Acronym / sponsor ID
- OBID / EudraCT number: 2020-001980-95
- Conditions
- Bipolar Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Arvid Carlsson Research AB
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open study
| Arm | Type | Receives |
|---|---|---|
| OSU6162 | Experimental | Drug: OSU6162Coated tablet, flexible dosing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent
- Voluntary admission to the psychiatric ward prior or directly after the screening point
- Age: 18-65 on the day of screening
- 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)
- Displaying a sum score of ≥10 on the Bech 6-item subscale of the Hamilton Depression rating Scale.
Key exclusion criteria (18 listed)
- Ongoing compulsory care.
- Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- Previously diagnosed or meeting MINI criteria at interview for obsessive-compulsive disorder or post-traumatic stress disorder.
- A previous diagnosis of a personality disorder, autism, ADHD, or intellectual disability.
- A history of substance/alcohol abuse within 2 years prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSU6162OSU6162 | Drug | OSU6162 |
Primary outcome
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) at endpoint [Day 60].
Time frame: Endpoint at 60 days treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OSU6162 in people with Bipolar Depression, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elias Eriksson, Professor (+ 46 709 555055, elias.eriksson@neuro.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) at endpoint [Day 60]. (time frame: Endpoint at 60 days treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.