OSU6162 in Bipolar Depression: An Open-label, Flexible Dose Study (OBID)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Of Gothenburg

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2024-10-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517560-30-00

EudraCT number

2020-001980-95

ClinicalTrials.gov

NCT05296356

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Dose response, Therapy

To achieve a preliminary assessment of the possible efficacy and of the tolerability of OSU6162 in bipolar depression.

Conditions and MedDRA coding

Bipolar depression

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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.

Exclusion criteria 1

1. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) [Time Frame: Day 0, 5, 12, 30, 45, 60].

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Gothenburg

Sponsor organisation

University Of Gothenburg

Address

P. O. Box 100

City

Gothenburg

Postcode

405 30

Country

Sweden

Scientific contact point

Organisation

University Of Gothenburg

Contact name

Elias Eriksson

Public contact point

Organisation

University Of Gothenburg

Contact name

Elias Eriksson

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications