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    Summary
    EudraCT Number:2015-000465-31
    Sponsor's Protocol Code Number:CannaBiD
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-03-30
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2015-000465-31
    A.3Full title of the trial
    Cannabidiol in Bipolar Depression – CannaBiD-Study: An 8-week randomized, double-blind, placebo-controlled clinical trial of Cannabidiol as add-on therapy in bipolar depression
    Cannabidiol in bipolarer Depression – CannaBiD-Studie: Eine 8-wöchige, randomisierte, doppelblinde, placebo-kontrollierte klinische Studie mit Cannabidiol als Add-on-Therapie zur Behandlung der bipolaren Depression
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An 8-week randomized, double-blind, placebo-controlled clinical trial of Cannabidiol as add-on therapy in bipolar depression
    Eine 8-wöchige, randomisierte, doppelblinde, placebo-kontrollierte klinische Studie mit Cannabidiol als Add-on-Therapie zur Behandlung der bipolaren Depression
    A.3.2Name or abbreviated title of the trial where available
    CannaBiD-Study
    A.4.1Sponsor's protocol code numberCannaBiD
    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 SponsorCharité - Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportCharité - Universitätsmedizin Berlin
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressChariteplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number049030450617056
    B.5.5Fax number019030450517921
    B.5.6E-mailjohannes.rentzsch@charite.de
    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 nameCannabidiol
    D.3.2Product code CBD
    D.3.4Pharmaceutical form Capsule, hard
    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 INNCannabidiol
    D.3.9.1CAS number 13956-29-1
    D.3.9.2Current sponsor codeCannabidiol
    D.3.9.3Other descriptive nameCANNABIDIOL
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Bipolar disorder, current episode depressed
    Bipolare affektive Störung, gegenwärtig depressive Episode
    E.1.1.1Medical condition in easily understood language
    Bipolar disorder, current episode depressed
    aktuelle depressive Episode bei einer Bipolaren Störung
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10004936
    E.1.2Term Bipolar depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10057667
    E.1.2Term Bipolar disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10026756
    E.1.2Term Manic depressive illness
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10026755
    E.1.2Term Manic depressive
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10004911
    E.1.2Term Bipolar affective disorder, depressed
    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
    Efficacy of CBD compared to placebo as add-on treatment to mood-stabilizers in the treatment of patients with an acute episode of bipolar depression in the reduction of depressive symptoms after 8 week of treatment.
    E.2.2Secondary objectives of the trial
    Efficacy of CBD add-on treatment compared to placebo in:
    - reduction of symptoms of anxiety after 8 week of treatment.
    - in improvement of quality of life after 8 week of treatment.
    - in reduction of self-rated depressive symptoms after 8 week of treatment.
    - in the overall clinical improvement (CGI-BP) of depression after 8 week of treatment.
    - Number of patients in early improvement, response or remission (wk 2, wk 4, wk 8).
    - Improvement of depressive symptoms and symptoms of anxiety to any timepoint
    Safety: manic symptoms and mania requiring treatment; adverse events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - male and female in- and outpatients between 18 – 65 years with a Bipolar Disorder (DSM-V) and a current acute depressive episode (HDRS-17 > 17) with no current manic symptoms (YMRS < 12)
    - no treatment with any antidepressant agent (i.e. any medication which is licensed as monotherapy for the treatment of unipolar depression) within the last 2 weeks
    - written informed consent
    - ability to understand and comply with the requirements of the study
    - capability to give informed consent
    - Women: negative serum human chorionic gonadotropin
    - highly effective method of contraception
    E.4Principal exclusion criteria
    - pregnant or nursing women
    - a clinically significant medical illness
    - a current psychiatric disorder which is the primary focus of treatment other than Bipolar Disorder
    - current treatment with quetiapine
    - current diagnosis or history of schizophrenia/ schizoaffective disorder, mental retardation, organic mental disorder, or mental disorder due to a general medical condition
    - current diagnosis or history of alcohol or other substance abuse/ dependency (excluding nicotine or caffeine) that has not been in full and sustained remission for at least 3 month
    - any Axis II disorder that might compromise the study
    - serious suicidal risk or harm for others;
    - a current bipolar disorder with psychotic features
    - a current history of rapid cycling
    - any medical condition which will be defines as “unstable”, which means that a clinical relevant change within the next 8 weeks has to be considered
    - any medical diagnostic intervention which results will give reasons for the beginning of a pharmacological or surgical therapy which have to start within the next 8 weeks
    - planed krankenhausaufenthalt within the study period
    - non-compensated hypo- or hyperthyreosis
    - inpatient treatment by legal order
    - known hepatitis type B or C, a known HIV infection or known maligne disorder
    - any patients which will not agree to the given birth control method
    - cannabinoide intolerance
    E.5 End points
    E.5.1Primary end point(s)
    change in HDRS-17 score
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 8
    E.5.2Secondary end point(s)
    - mean scores in HDRS-6, MADRS, STAI, HAMA, BDI-II, WHOQOL-BREF
    - early improvement (30% reduction), response (50% reduction), remitters (HDRS-17 < 8 or MADRS < 11)
    - Safety: manic symptoms (YMRS, AMI); mania requiring treatment; Antidepressant Side-Effect Checklist; Hematology tests and Clinical chemistry; ECG; Blood pressure; Heart rate; Body weight
    E.5.2.1Timepoint(s) of evaluation of this end point
    - mean scores: week 8 and any time point
    - early improvement week 2, response week 4 or 8, remitters week 4 or week 8
    - Safety: any time point
    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 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 Yes
    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 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 Yes
    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 years4
    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: 106
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state126
    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)
    Thelephone visit
    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 Decision2016-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-11-25
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