Depression Bipolar disorder
Conditions
Interventions
Product Name: OSU6162
Product Code: OSU6162
Pharmaceutical Form: Coated tablet
Sponsors
University of Gothenburg
Eligibility
Sex/Gender
All
Inclusion 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 disorder, 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 age: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 somatic illness resulting from assessment of vital signs, physical examination, clinical laboratory tests and 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 with 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate whether there are indications that the monoaminergic stabilizer OSU6162 may prove an effective and relatively fast-acting treatment for bipolar depression as assessed using the sum rating of the MADRS as measure of depression severity. ;Secondary Objective: 1) to explore possible effects of OSU6162 on cognitive functioning 2) to explore possible effects of OSU6162 on concomitant anhedonia and mixed-symptoms in bipolar depression 3) to explore possible effects of OSU6162 on blood-based markers of depression outcomes 4) to explore the occurrence of OSU6162-elicited adverse events 5) to gain some preliminary insight into the effect of tolerability of different doses of OSU6162 ;Primary end point(s): Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) [Time Frame: Day 0, 5, 12, 30, 45, 60]. ;Timepoint(s) of evaluation of this end point: Time Frame: Day 0, 5, 12, 30, 45, 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in concomitant manic or mixed symptoms will be measured with clinical investigator rating scales as well as self-assessment rating scales from Baseline to Day 5, 12, 20, 30, 45, 60. Blood samples will be taken during the study period (day 0, 5, 12, 30, 60). Change in cognitive functioning will be measured with computer-based cognitive tests.;Timepoint(s) of evaluation of this end point: See above: E.5.2 | — |
Countries
Sweden
Contacts
Public ContactElias Eriksson
University of Gothenburg
Outcome results
None listed