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    Summary
    EudraCT Number:2022-002757-26
    Sponsor's Protocol Code Number:BH-200-03
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-12-20
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2022-002757-26
    A.3Full title of the trial
    A 14-week, multicentre, double-blind, randomised, placebo-controlled phase II study with an 8-week treatment period to assess the efficacy and tolerability of a fixed dose of BH-200 (250 mg BID) in outpatients with Major Depressive Disorder (MDD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    .
    A.3.2Name or abbreviated title of the trial where available
    OLIVE
    A.4.1Sponsor's protocol code numberBH-200-03
    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 SponsorHMNC Holding GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHMNC Holding GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHMNC Holding GmbH
    B.5.2Functional name of contact pointHans Eriksson
    B.5.3 Address:
    B.5.3.1Street AddressWilhelm-Wagenfeld-Strasse 20
    B.5.3.2Town/ cityMunchen
    B.5.3.3Post code80807
    B.5.3.4CountryGermany
    B.5.4Telephone number+4673968 75 22
    B.5.6E-mailhans.eriksson@hmnc-brainhealth.com
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNelivaptan
    D.3.2Product code BH-200
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNelivaptan
    D.3.9.1CAS number 439687-69-1
    D.3.9.2Current sponsor codeBH-200
    D.3.9.4EV Substance CodeSUB223777
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNelivaptan
    D.3.2Product code BH-200
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNelivaptan
    D.3.9.1CAS number 439687-69-1
    D.3.9.2Current sponsor codeBH-200
    D.3.9.4EV Substance CodeSUB223777
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major Depressive Disorder
    E.1.1.1Medical condition in easily understood language
    Depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of BH-200 (250 mg BID) versus placebo in improving depressive symptoms in V1b polygenic score-high (V1b-high) patients.
    E.2.2Secondary objectives of the trial
    - To compare the improvement of depressive symptoms in V1b-high versus V1b-low patients treated with BH-200 (250 mg BID).
    - To test whether efficacy of BH-200 versus placebo differs in different V1b-classifications (V1b-treatment interaction).
    - To explore the efficacy of BH-200 (250 mg BID) on response rate, remission rate, and quality of life and compare these outcomes across all three V1b-classifcations as well as treatment arms.
    - To compare the outcome in placebo-treated V1b-high versus V1b-low patients.
    - To assess the efficacy of BH-200 (250 mg BID) in improving anxiety symptoms in V1b-high versus V1b-low patients.
    - To explore the tolerability and safety of BH-200 (250 mg BID).
    - To explore plasma concentrations of BH-200.
    - To explore the association of demography, depression and treatment effects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients.
    2. Between 18 and 75 years of age at the date of informed consent.
    3. Body mass index between 18 and 35 kg/m2.
    4. Outpatients.
    5. Ability of the participant to understand the purpose and risks of the study and provide signed and dated initial informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
    6. Provide written informed consent.
    7. Primary diagnosis of MDD, moderate or severe, single or recurrent episode, with or without psychotic features as defined by Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI). However, patients with the following co-morbid conditions can be included (secondary diagnosis):
    a) Patients with anxiety disorders as long as the primary diagnosis is MDD.
    b) Patients with obsessive-compulsive disorder as long as the primary diagnosis is MDD and the current condition is not impairing/disabling or interfering with the patient’s adherence to study drug and protocol.
    c) Patients with eating disorders as long as the primary diagnosis is MDD and the condition does not impact the efficacy of the study drug or raise safety concerns in the investigator’s opinion.
    8. MADRS score ≥20 at screening and baseline.
    9. Duration of current episode no longer than 12 months, prior to screening.
    10. Symptoms of depression present for at least 2 weeks, prior to screening.
    11. Willingness to stop current antidepressive medication or other prohibited psychotropic medication, at least 7 days or 5 half-lives, whichever is longer, before baseline (day 0).
    12. Psychotherapy that has been ongoing for a minimum of 6 weeks prior to screening can continue, but new psychotherapy may not be initiated from 6 weeks prior to screening until 8 weeks after start of treatment.
    13. Physical activity programmes that have been ongoing for a minimum of 6 weeks prior to screening can continue but should be kept on the same level (i.e., type and frequency), but new physical activity programmes may not be initiated from 6 weeks prior to screening until 8 weeks after start of treatment.
    14. Ongoing hormone substitution therapy for post-menopausal women, insulin treatment for diabetes and thyroid disorders is allowed as long as these conditions are well controlled
    15. Women of childbearing potential will be required to use highly effective contraceptive measures from the time of informed consent until 28 days after last intake of the investigational drug.
    16. Male patients will be required to use highly effective contraceptive measures (barrier method) or practice abstinence during this study and for 28 days after last intake of investigational drug.
    E.4Principal exclusion criteria
    1. Inability to obtain written informed consent from the patient or to comply with the protocol and follow written and verbal instructions.
    2. Pregnant, lactating females.
    3. Patients with schizophrenia spectrum and other psychotic disorders and bipolar disorders.
    4. Patients with paranoid, schizoid, and schizotypal personality disorder.
    5. Patients with antisocial, borderline (emotionally unstable personality disorder, borderline type), histrionic and narcissistic personality disorder.
    6. Patients with intellectual disability / mental retardation, e.g., due to neurodevelopmental disorders, neurocognitive or neurodegenerative disorders, and autism spectrum disorder.
    7. Patients with PTSD.
    8. Significant risk of suicide.
    9. Patients with known or suspected lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder, epilepsy, or any other disease/procedure/accident/intervention which, according to the screening clinician, is deemed associated with significant injury to or malfunction of the CNS, or history of significant head trauma within the past 2 years prior to screening, with the exception of uncomplicated childhood febrile seizures with no sequelae.
    10. Patients with known or suspected cardiovascular or cerebrovascular disease (e.g., unstable angina, congestive heart failure, tachyarrhythmia, myocardial infarction, stroke, prolonged ischaemic neurologic deficit and transient ischaemic attack), as well as patients who have:
    -Abnormal ECG at screening
    -Heart rate <50 or >110 beats per minute at screening or baseline.
    -History of sudden cardiac death in a first degree relative.
    -Patients with untreated hypertension and a systolic blood pressure (BP) at rest >160 mmHg and/or diastolic BP at rest >100 mmHg.
    11. Patients with a history of, or symptoms and signs suggestive of, impaired hepatic function or cirrhosis.
    12. Patients with a history of Hepatitis B or C.
    13. Patients with Cushing’s Syndrome.
    14. Patients with Addison’s Disease.
    15. Renal insufficiency.
    16. Patients with uncontrolled diabetes (glycated haemoglobin [HbA1c] >8.0% at screening).
    17. Patients with known but untreated conditions causing hyperthyroidism or hypothyroidism with the following exceptions:
    -Patients with a pre-existing history of hypothyroidism who are treated with thyroid hormones must be on a stable dosage for 6 weeks before baseline, are allowed into the study.
    -Patient must have thyroid stimulating hormone (TSH) and free thyroxine (fT4) within normal range at screening. If there is a low TSH or high fT4 in a patient on levothyroxine, the patient could be re-screened after re-adjustment of levothyroxine dose and in-range levels of TSH and fT4 are attained.
    -Patients on thyroid suppressant medication.
    18. Patients with any significant disease or disorder (e.g., cardiovascular, haematological, pulmonary/respiratory, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study.
    19. Patients with a history of moderate to severe alcohol use and/or substance use disorder.
    20. Prior intermittent use of cannabinoids prior to screening is not exclusionary if the patient does not meet the criteria for substance use disorder.
    21. A urinary drug screening test using a multi-drug dipstick will be performed at screening. Patients tested positive of any drug of abuse (e.g., MDMA, amphetamine, opiates, barbiturates, cocaine, benzodiazepines, cannabis) will be excluded from the study with the following exceptions:
    a) Patients tested positive for cannabis must be counselled to abstain from cannabis use during the study. They can be included, if, in the judgement of the investigator, the patient will comply.
    b) Intake of cannabis during the study is prohibited unless the patient has a valid prescription where local legislation permits.
    c) Intake of benzodiazepines during the study is prohibited unless the patient has a valid prescription.
    22. Patients that received fluoxetine treatment within 10 weeks prior to screening
    23. Patients who donated or lost whole blood ≥500 mL within 2 weeks prior to first dosing.
    24. Patients who have participated in 2 or more clinical interventional studies within 1 year before screening.
    25. Patients who are currently enrolled in a clinical interventional study.
    E.5 End points
    E.5.1Primary end point(s)
    Change in the 17-item Hamilton Depression Rating Scale (HAMD-17) total score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to visit 7.
    E.5.2Secondary end point(s)
    -Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
    -Response rate.
    -Remission rate.
    -Change in the HAMD-17 total score.
    -Change in the Clinical Global Impression-Severity of Illness rating scale (CGI-S).
    -Change in the Hospital Anxiety and Depression Scale (HADS) total score, depressive sub-score, and anxiety sub-score.
    -Change in the 36-item Short Form Health Survey (SF-36, one-week recall version).
    -Change in the Sheehan Disability Scale (SDS).
    -Change in suicidality, assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).
    -Number of reported adverse events (AEs), serious AEs (SAEs), number of reported clinical safety abnormalities (safety laboratory, electrocardiogram [ECG]).
    -Pharmacokinetic (PK) assessments.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -MADRS - from baseline to each planned post-baseline visit, where the MADRS is assessed (visit 5, visit 7 and visit 8 [follow-up visit]).
    -Response rate, Remission rate, HAMD-17, CGI-S and HADS – at each post-baseline visit.
    -SF-36, one-week recall version - from baseline to each planned post-baseline visit, where the SF-36 is assessed (visit 5, visit 7 and visit 8 [follow-up visit]).
    -SDS and C-SSRS - from baseline to each planned post-baseline visit.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Serbia
    Bulgaria
    Estonia
    Germany
    Lithuania
    Poland
    Slovakia
    Spain
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 259
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 Yes
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 274
    F.4.2.2In the whole clinical trial 324
    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)
    None
    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 Decision2023-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-14
    P. End of Trial
    P.End of Trial StatusOngoing
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