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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-000525-60
    Sponsor's Protocol Code Number:750801.01.017
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-05
    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 number2006-000525-60
    A.3Full title of the trial
    Multi-center, double-blind, placebo-controlled, randomized phase III study to demonstrate the efficacy and investigate the safety of Hypericum extract WS® 5570 in patients with a Major Depressive Episode of moderate severity
    A.4.1Sponsor's protocol code number750801.01.017
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDr. Willmar Schwabe GmbH & Co. KG
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameHypericum Extrakt WS 5570
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 placeboFilm-coated tablet
    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 episode according to DSM-IV (single episode: 296.22, recurrent episode: 296.32; duration at least two weeks but not longer than one year).
    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 aim of the study is to confirm the clinical efficacy and safety of Hypericum extract WS® 5570 in a twice a day application schedule in patients with a major depressive episode of moderate severity with the selected rating scales 17-HAMD, BDI, CGI, SF-36, DISS and global rating of satisfaction with therapy result.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Age => 18 years and <= 65 years
    2. Informed consent in accordance with the legal requirements
    3. Diagnosis of a major depressive episode of moderate severity according to DSM-IV (single episode: 296.22, recurrent episode: 296.32; duration at least two weeks but not longer than one year). Anxiety may be present if not requiring specific treatment.
    4. Severity of depression on the baseline visit: 17-HAMD total score => 22 and HAMD item “depressive mood” => 2
    5. Patient is able to comply with the physician’s instructions and to fill in the self rating scales
    E.4Principal exclusion criteria
    1. Participation in a further clinical trial at the same time or within the past 4 weeks
    2. Any of the following psychiatric diagnosis according to DSM-IV: schizophrenia (295.x, 297.x, 298.x), acute anxiety disorder (300.x, 302.x) as primary diagnosis, adjustment disorder (309.x), episodes of depression with any characteristics of a psychotic nature (296.24, 296.34) depressive disorders not defined as inclusion criteria (e.g. 300.4, 311), bipolar disorder (296.0, 296.4, 296.5, 296.6, 296.7, 296.8, 301.13), organic mental disorder (ICD-10: F06), acute post traumatic stress disorder (309.81), abuse of any substance
    3. Risk of suicide, or previous suicide attempt or clear display of auto-aggresive behaviour
    4. Lack of response to any adequate antidepressant therapy in the present episode of depression (adequate means => 150 mg amitriptyline-equivalents per day or SSRI treatment during at least 6 weeks)
    5. Duration of the index episode > 1 year
    6. Any of the following treatments within the indicated intervals before baseline visit: depot neuroleptics (2 months), MAO inhibitors (6 weeks, exception: moclobemide or other RIMAs), fluoxetine (6 weeks), benzodiazepines (2 weeks), other psychotropic drugs (1 week)
    7. Non-medical psychiatric treatment during the last two weeks (e.g. standardised psychotherapy, sleep withdrawal, phototherapy, ECT)
    8. Prohibited concomitant medication: any psychotropic drug (incl. benzodiazepines), antihypertensive medication with guanethidine, guanoxan, clonidin, prazosine, a-methyldopa, sedative drugs including antihistaminics (exception: <= 10 mg Stilnox® (zolpidem)/day), longterm prophylactic treatment (e.g. lithium, carbamazepine), reserpine, coumarine derivates, ciclosporine, digoxin, indinavir and other protease inhibitors in anti HIV treatment, theophylline
    9. History of hypersensitivity to hypericum extract
    10. Known photosensitivity
    11. Any clinically relevant hepatic, renal, cardiovascular, respiratory, cerebrovascular, metabolic disorder or progressive diseases as cancer, haematologic diseases or thyroid insufficiency (exception: metabolic diseases like diabetes mellitus or anterior pituitary insufficiency on stable treatment), epilepsy or a history of seizure disorder or treatment with anticonvulsants for epilepsy or seizures, Parkinson’s disease
    12. Pregnancy or lactation
    13. Patients capable of childbearing if not using adequate contraception (intra-uterine devices or injectable contraception; if hormonal oral contraceptives are used, a second contraception such as condoms are mandatory)
    14. Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is defined as: change from baseline (visit 2) to the individual last visit (visit 6 = day 71; visit 10 = day 183 or last day in study in case of premature termination) in the 17-HAMD total score. For confirmatory analysis, the difference to day 71 (visit 6) or last visit in the acute treatment phase in case of premature termination will be considered. For descriptive analysis of the continuation phase the difference between baseline (visit 2) and day 183 (visit 10) or last visit in the continuation phase in case of premature termination as well as between day 71 (visit 6) and day 183 (visit 10) or last visit in the continuation phase in case of premature termination will be observed.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.3 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.8.5The 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    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 months2
    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 months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-04-05. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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)
    If necessary, standard therapy can be applied further.
    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 Decision2006-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-27
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