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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41499   clinical trials with a EudraCT protocol, of which   6826   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2007-004613-34
    Sponsor's Protocol Code Number:NordLOTS protocol 1.4
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-10-24
    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 ConcernedSweden - MPA
    A.2EudraCT number2007-004613-34
    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
    A.4.1Sponsor's protocol code numberNordLOTS protocol 1.4
    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 Norway (R.BUP)
    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 Zoloft or generic Sertralin preparations
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer plus other pharm. comp.
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameSertraline
    D.3.4Pharmaceutical form Tablet
    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 INNSERTRALINE
    D.3.9.1CAS number 79617962
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    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
    MedDRA Classification
    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 Obsession
    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 Compulsions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To find best treatment for children and adolescents with OCD who are partial- or non-responders to Cognitive Behavioural Therapy (CBT). CBT (14 session) is the treatment of choice in pediatric OCD. About a third of the patients are non- or partial responders. Non- or partial responders to CBT are randomised (Step 2) to either continued CBT or to Sertraline (with continued CBT support) to find an optimal treatment strategy: an increased "dose" of CBT or medication with Sertraline together with CBT-support. No study has studied SSRI effectiveness in CBT non- or partial responders.
    E.2.2Secondary objectives of the trial
    To identify predictors, moderators and mediators of good and non- or partial Sertraline- respectively CBT response in non- or partial pediatric OCD CBT responders (step2).
    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.

    Magnetkameraundersökning av glutamat/glutamin-koncentrationen i hjärnan vid tvångstillstånd (OCD: Objective: to investigate functional brain abnormalities in pediatric OCD using Magnet resonance spectroscopy (MRS) in parts of the Cortici-Strtiatal. Thamalic-Cortical loops that are believed to be the one where the brain substrate of the OCD symptoms are situated. MRS can be used to identify glutamat concentration of the various parts of this functional loop. Also, substances that are associated with the vitality of components in the loop can be guaged.

    Backgroundsfactors and outcome in pediatric OCD: Objective to study various correlates and possible backgroundsfactors in pediatric OCD. Also, evaluating various scales and interviews used in pediatric OCD. The study stated 1/1 2001 and we have published several papers and the naturalistic outcome at 6 and 12 months of a five year cohort.
    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 patients included in step 2, involving Sertralin have failed an adequate trial of CBT for 14 sessions (in step 1), i.e. that CY-BOCS scores are still 16 or above.All co-morbidities are allowed except as defined below.
    E.4Principal exclusion criteria
    patient has been treated with CBT or Sertraline in the last year 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 2 respectively step 3. Responder 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 (at +6, +12, +24 and +36 months) using the CY-BOCS and the stability of the treatment gains can thus be established. 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 Yes
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 Yes
    E.6.13.1Other scope of the trial description
    effectiveness
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    effectiveness
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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 Yes
    E.8.2.3.1Comparator description
    Cognitive Behaviour Therapy
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 any treatment (i.e. CBT or Sertraline) in step 2 is inferior to the other and no sub-groups have markedly better response in either form of therapy, then 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 months6
    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 months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 300
    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 symptomatic will be referred to the local child- and adolescent psychiatry unit. As the trial includes the treatments that are evidence based (i.e. CBT and SSRI treatments), and the patients within the design of the study will be non- or partially responding patients, it is to be presumed that different 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 Decision2008-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-07
    P. End of Trial
    P.End of Trial StatusOngoing
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