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    Summary
    EudraCT Number:2009-011115-20
    Sponsor's Protocol Code Number:NordLOTS protocol step 3 1.1
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-02-01
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2009-011115-20
    A.3Full title of the trial
    Nordic Longterm OCD treatment Study: A Nordic Multicenter treatment study evaluating a stepped
    care model based on the "Expert Clinical Guidelines". The study is performed with no sponsor from
    pharmaceutical firms
    A.3.2Name or abbreviated title of the trial where available
    NordLOTS step 3
    A.4.1Sponsor's protocol code numberNordLOTS protocol step 3 1.1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN66385119
    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 SponsorThe Centre for Child and Adolescent Mental Health, Eastern and Southern
    B.1.3.4CountryNorway
    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 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 Yes
    D.2.1.1.1Trade name Abilify
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 namearipripazol, abilify
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    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) 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 No
    D.3.11.8Extractive medicinal product No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obsessive Compulsive Disorder (OCD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010219
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049596
    E.1.2Term <Manually entered code. Term in E.1.1>
    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 aripirazol (Abilify) as an augmenting strategy of sertraline treatment for children and adolescents
    with OCD who are treatment refractory to evidence based treatments.
    Status as treatment refractory is defined by lack of adequate response to Cognitive Behavioural Therapy (CBT)
    followed by an adequate trial of Sertraline plus continued CBT-support.
    Arpiprazol has unique pharmacological properties due to dopamine stabilising and mixed Serotonin agonistic and
    blocking actions (depending on 5-HT receptor subtype) that will augment the effect of sertraline on OCD.
    E.2.2Secondary objectives of the trial
    To identify predictors, moderators and mediators of good and non- or partial Aripiprazole plus Sertraline
    response in treatment refractory pediatric OCD-patients.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Molecular genetic aspects of Obsessive Compulsive Disorder (OCD) and OCD treatment response: Objective:
    to identify genetic markers that (1) are characteristic of pediatric OCD patients (trio-design); (2) identify
    genetic markers that are characteristic of CBT responders and CBT non- or partial responders; (3) identify
    genetic markers that are characteristic of Sertraline responders respectively non-responders to CBT non- or
    partial responders.

    Backgroundsfactors and outcome in pediatric OCD: Objective to study various correlates and possible
    backgroundsfactors, e.g. psychosocial and psychiatric co-morbidity and OCD symptom patterns etc. in
    pediatric OCD. Also, evaluating various scales and interviews used in pediatric OCD.
    E.3Principal inclusion criteria
    Obsessive Compulsive Disorder according to DSM IV of moderate-severe type in patients aged 7-17. Severity
    as defined by Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Scores of 16 or above. All comorbidities
    are allowed except as defined below. All patients included in step 3, involving Aripirazole have failed
    an adequate trial of CBT for 14 sessions (in step 1 and if applicable in step 2) and a subsequent adequate trial of
    sertraline, i.e. that CY-BOCS scores are still 16 or above.
    Thus, the patient has OCD that is treatment refractory to evidence based treatments, which is the inclusion
    criterion for step 3 of the NordLOTS
    E.4Principal exclusion criteria
    patient has been treated with CBT or Sertraline in the 6 months preceding inclusion in step 1 for OCD. Other
    psychiatric disorder with higher treatment priority (e.g. acute psychosis, suicidality in major depression, severe
    Anorexia nervosa). Mental retardation, Autism and Asperger's syndrome. Patient and/or parent does not
    understand or can speak the language. Comorbidity with ADHD, bipolar disorder etc are allowed if the patient is
    stabilised on the appropriate drug for at least 3 months.
    E.5 End points
    E.5.1Primary end point(s)
    CYBOCS scores at 8 weeks and 3 months after inclusion in step 3. Responder status as good is defined as the
    patient having reduced their CYBOCS scores to 11-15 points. Excellent response is defined as CY-BOCS scores
    of 10 or below. Responders will be followed up for up to 36 months (from inclusion in step 1) (at +12, +24
    and +36 months counted from inclusion in step 1) using the CY-BOCS and the stability of the treatment gains
    can thus be established. We will as well investigate the possibility to terminate the medication without relapse
    (Aripiprazole first followed by sertraline) using the same criteria. The Clinical Global Impression (CGI) and
    Clinical global Improvement (CGIimp) will be used at the same timepoints.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Dr Pål Zeiner M.D., Ph.D. , BUP, Drammen, Norway is the trial monitor with full access to data and powers to
    stop the trial. He is not part of the NordLOTS study or NordLOTS steering group.
    If the trial monitor finds that the treatment (i.e. Aripiprazole) in step 3 leads to inadequate outcome and that no
    sub-groups have markedly better response the monitor is to stop the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    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 2011-02-01. Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    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)
    Patients who are still ill will be referred to the local child psychiatric unit. Following CBT and SSRI treatments,
    and following that augmenting sertraline with Aripiprazole the patients within the design of the study will be
    fully treatment refractory/non-responding patients. It is to be presumed that further augmentation strategies will
    have to be used (e.g. other atypical neuroleptics or clomipramine treatment) supplementing CBT and various
    family support methods.
    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 Decision2011-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-06-27
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