Evaluation of OSU6162 Hydrochloride in the Treatment of Bipolar Depression: An Open-label, Flexible Dose Study
- Trial ID
- 2024-517560-30-00
- Sponsor
- University Of Gothenburg
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to achieve a preliminary assessment of the possible **efficacy** and tolerability of **OSU6162** in individuals with **bipolar depression**. This is clinically relevant as it aims to explore a potential therapeutic option for managing symptoms of bipolar depression, a condition characterized by depressive episodes that can significantly impact quality of life. The study will evaluate the effects of OSU6162, a dopaminergic stabilizer, administered in a flexible dose regimen, to determine its potential benefits and safety profile in this patient population.
Participants
The clinical trial focuses on individuals diagnosed with **bipolar depression**, specifically targeting those experiencing a depressive episode in Bipolar Disorder type I or type II. The study population includes both male and female participants, aged between 18 and 65 years. Participants are required to have a stable dose of a mood stabilizer for at least four weeks prior to screening. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Key lifestyle considerations include the use of effective contraception methods for female participants of childbearing potential and the requirement for male participants to use condoms unless their partner is using a highly efficient method of contraception. The selection criteria ensure that participants meet the DSM-5 criteria for a depressive episode, confirmed by the Mini International Neuropsychiatric Interview (MINI), and display a sum score of ≥10 on the Bech 6-item subscale of the Hamilton Depression Rating Scale.
Plans and Procedures
The clinical trial is designed to evaluate the **efficacy** and tolerability of OSU6162 in individuals with **bipolar depression**. This study is an open-label, flexible dose trial, classified as Phase 4, and is not considered low intervention. The trial will involve the administration of OSU6162, a dopaminergic stabilizer, in the form of a 15 mg coated tablet, taken orally. The maximum daily dose is set at 135 mg, with a total treatment period of up to 8 weeks. The primary endpoint is the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) at specified time points: Day 0, 5, 12, 30, 45, and 60.
Participants will be involved in the study for a duration of approximately 8 weeks, with the trial estimated to conclude by March 31, 2026. The sequence of study visits includes an initial screening visit to confirm eligibility based on criteria such as age, diagnosis, and current treatment regimen. Following the screening, participants will undergo regular follow-up visits to monitor their response to the treatment and any potential side effects. The end-of-study visit will assess the overall outcomes and gather final data for analysis.
Inclusion criteria require participants to be between 18 and 65 years old, meet DSM-5 criteria for a depressive episode in Bipolar Disorder type I or II, and have a stable dose of a mood stabilizer for at least four weeks prior to screening. Female participants of childbearing potential must use a highly effective method of contraception, and male participants must agree to use condoms during the study and for two weeks after the last dose. Conditions that may lead to early termination from the study include non-compliance with the study protocol, adverse reactions, or withdrawal of consent.
Treatment
The clinical trial involves the administration of **OSU6162**, a dopaminergic stabilizer, as the experimental medication. **OSU6162** is formulated as a **coated tablet** containing 15 mg of the active substance **3-(3-methanesulfonyl-phenyl)-1-propyl-piperidine hydrochloride**. The medication is administered **orally**. The dosing regimen is flexible, with a maximum daily dose of 135 mg, and the treatment period extends up to 8 weeks. The chemical origin of the active substance is confirmed, and it is not classified as a pediatric formulation. The trial aims to assess the preliminary efficacy and tolerability of **OSU6162** in patients with bipolar depression.
In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The focus remains solely on the administration of the experimental medication, **OSU6162**. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the prescribed regimen. The trial is conducted under the auspices of Sahlgrenska University Hospital, ensuring adherence to rigorous clinical standards.
Efficacy
Efficacy in the clinical trial titled "OSU6162 in Bipolar Depression: An Open-label, Flexible Dose Study (OBID)" will be assessed primarily through the **Montgomery-Åsberg Depression Rating Scale (MADRS)**. The primary endpoint is the change from baseline in MADRS scores, which will be measured at specific time points: Day 0, Day 5, Day 12, Day 30, Day 45, and Day 60. This scale is a validated tool commonly used to evaluate the severity of depressive episodes in patients with bipolar disorder. The trial aims to provide a preliminary assessment of the efficacy and tolerability of OSU6162, a dopaminergic stabilizer, in treating bipolar depression. The study will involve flexible dosing of OSU6162, with a maximum daily dose of 135 mg, administered orally in the form of coated tablets. The trial is designed to last for a maximum treatment period of 8 weeks. Data collection and analysis will focus on the changes in MADRS scores over the specified time frame to determine the potential benefits of the investigational product in managing symptoms of bipolar depression.
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Sweden | Not Yet Recruiting | 24 Oct 2021 | 22 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
OSU6162 15 mg | Test | COATED TABLET | ORAL | 135.00 | 8 | PRD11370656 |