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    Summary
    EudraCT Number:2020-001980-95
    Sponsor's Protocol Code Number:OBID
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-12-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2020-001980-95
    A.3Full title of the trial
    OSU6162 in bipolar depression: an open-label, flexible dose study (OBID)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OSU6162 in bipolar depression: an open-label, flexible dose study (OBID)
    A.3.2Name or abbreviated title of the trial where available
    OBID
    A.4.1Sponsor's protocol code numberOBID
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Gothenburg
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Gothenburg
    B.5.2Functional name of contact pointElias Eriksson
    B.5.3 Address:
    B.5.3.1Street AddressPOB 431
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code405 30
    B.5.3.4CountrySweden
    B.5.4Telephone number+46709555055
    B.5.6E-mailelias.eriksson@neuro.gu.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOSU6162
    D.3.2Product code OSU6162
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Depression Bipolar disorder
    E.1.1.1Medical condition in easily understood language
    Depression and Bipolar disorder
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) [Time Frame: Day 0, 5, 12, 30, 45, 60].

    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame: Day 0, 5, 12, 30, 45, 60.
    E.5.2Secondary 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See above: E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 22
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Regular treatment
    Sedvanlig behandling
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-02
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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