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New treatment option for Bipolar Depression
Official title OSU6162 in Bipolar Depression (OBID)
ClinicalTrials.gov ID: NCT05296356
What this study is testing
What is OSU6162?
OSU6162 is an investigational medicine, being studied as a potential treatment for bipolar depression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Displaying a sum score of ≥10 on the Bech 6-item subscale of the Hamilton Depression rating Scale.
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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).
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.