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    Summary
    EudraCT Number:2011-004690-87
    Sponsor's Protocol Code Number:D6702C00031
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-12
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2011-004690-87
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients with Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the effect and safety of AZD6765 in patients with major depressive disorder.
    A.4.1Sponsor's protocol code numberD6702C00031
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01482221
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressN/a
    B.5.3.2Town/ cityN/a
    B.5.3.3Post codeN/a
    B.5.3.4CountrySweden
    B.5.6E-mailinformationcenter@astrazeneca.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 nameAZD6765 solution for infusion
    D.3.2Product code AZD6765
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLanicemine
    D.3.9.1CAS number 153322-06-6
    D.3.9.2Current sponsor codeAZD6765 2HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 1.0
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous 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 (MDD)
    E.1.1.1Medical condition in easily understood language
    Depression
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025453
    E.1.2Term Major depressive disorder NOS
    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 evaluate the efficacy of AZD6765iv (50 mg or 100 mg/infusion) as adjunct to current antidepressant medication versus antidepressant medication + placebo as assessed by the change from baseline to Week 6 in the MADRS total score in patients with MDD who exhibited an inadequate response to 3 or more different antidepressant treatments by history.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of AZD6765iv (50 mg and 100 mg )as adjunct to current antidepressant medication versus antidepressant medication + placebo in patients with MDD who exhibited an inadequate response to 3 or more different antidepressant treatments by history, as defined by:
    •Change from baseline to Week 12 in MADRS total score
    • Percentage of patients with sustained response from Week 6 to 12
    • Change from baseline in MADRS total score
    • Percentage of patients who are responders (defined as a ≥50% reduction from baseline on the MADRS total score)
    • Percentage of patients who are remitted (defined as a ≤8 on the MADRS total score)
    • Change from baseline in functional impairment as measured by the SDS total score
    • Change from baseline in severity of depressive symptoms as measured by Clinical CGI-S
    • Improvement of depressive symptoms as measured by CGI-I scale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Provision of signed and dated informed consent before initiation of any study-related procedures.
    2) Male or female patients aged 18 to 70 years, inclusive.
    3) The patient must have a clinical diagnosis of major depressive disorder with a lifetime history of inadequate response to at least 3 antidepressants.
    4) Women of child-bearing potential must have a negative serum pregnancy test and confirmed use of a highly effective form of birth control before enrollment for a minimum of 3 months before study start.
    5) Outpatient status at screening and randomization visits
    E.4Principal exclusion criteria
    1) Patients with a history of diagnosed bipolar disorder or schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression; dementia or suspicion thereof.
    2) Patients who have had a suicide attempt within the last 6 months.
    3) Electroconvulsive therapy (ECT), vagal nerve stimulation (VNS) or transcranial magnetic stimulation (TMS) or previous treatment with ketamine infusion within the 6 months prior to screening, or any history of deep brain stimulation.
    4) Patients with any history of seizure disorder (except for febrile seizures in childhood).
    5) Pregnancy or lactation.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of AZD6765iv (50 mg or 100 mg/infusion) as adjunct to current antidepressant medication versus antidepressant medication + placebo as assessed by the change from baseline to Week 6 in the MADRS total score in patients with MDD who exhibited an inadequate response to 3 or more different antidepressant treatments by history.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Will be scored at Weeks 1 (baseline), 2, 3, 4, 5 and 6
    E.5.2Secondary end point(s)
    To evaluate the efficacy of AZD6765iv (50 mg and 100 mg )as adjunct to current antidepressant medication versus antidepressant medication + placebo in patients with MDD who exhibited an inadequate response to 3 or more different antidepressant treatments by history, as defined by:
    1) Change from baseline to Week 12 in MADRS total score
    2) Percentage of patients with sustained response from Week 6 to 12
    3) Change from baseline in MADRS total score
    4) Percentage of patients who are responders (defined as a ≥50% reduction from baseline on the MADRS total score)
    5) Percentage of patients who are remitted (defined as a ≤8 on the MADRS total score)
    6) Change from baseline in functional impairment as measured by the Sheehan Disability Scale (SDS) total score
    7) Change from baseline in severity of depressive symptoms as measured by Clinical Global Impression-Severity of Illness (CGI-S) scale
    8) Improvement of depressive symptoms as measured by Clinical Global Impression-Improvement (CGI-I) scale
    9) Change from baseline in self-rated severity of depressive symptoms at each scheduled assessment as measured by Quick Inventory of Depressive Symptomatology Self-Report 16-item scale (QIDS-SR-16) total score.
    10) Adverse events (AEs)/serious adverse events (SAEs), including their severity.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10 and 12.
    2) same as above
    3) Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10, 12, 13, 14, 16, 18 and 20
    4) same as above
    5) same as above
    6) Will be scored at Weeks 1 (baseline), 6, 12 and 20
    7) Will be scored at Weeks 1 (baseline), 2, 3, 4, 5, 6, 8, 10, 12, 13, 16 and 20.
    8) Will be scored at Weeks 2, 3, 4, 5, 6, 8, 10, 12, 13, 16 and 20.
    9) Will be scored at Weeks 2, 3, 4, 5, 6, 8, 10, 12, 13, 16 and 20.
    10) Will be scored at Weeks 1 (baseline), 3, 6, 12, 16 and 20.
    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 trial3
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Chile
    Slovakia
    South Africa
    United States
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial 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: 252
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 282
    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)
    N/a
    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 Decision2012-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-23
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