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Bipolar Research And Innovation Network - BRAIN

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    2 amendments

    2 re-verifications since 2024-11-18, no change to tracked fields

    v22-v23

  2. Notable

    Primary endpoints: 1 to 2

    Secondary endpoints expanded, about 57 words; Publications: 2 to 7

    Show what changed: Primary endpoints
    characterizationDifference ofin bipolarremission Difference disordersin response
    Show what changed: Secondary endpoints
    GAF Current and concomitant medication SF36 MADRS IDS Inventory of depressive sympthoms CGI-BP Clinical Global Index - Bipolar PGI-1 (Patient global index) YMRS (Young mania rating scale) MSIF (Quality of life scale) MMS (Minimal mental scale) EMQ (Neuropsychology) UKU (Medication side effects) SAE- [...]
    Show what changed: Publications
    Kessler U, Vaaler AE, Schoyen H, Oedegaard KJ, Bergsholm P, Andreassen OA, Malt UF, Morken G. The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder. BMC Psychiatry. 2010 Feb 23;10:16. doi: 10.1186/1471-244X- [...]

    Study Identification, Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations, Referencesv21

  3. Minor

    4 amendments

    4 re-verifications since 2020-03-25, no change to tracked fields

    v17-v20

  4. Notable

    Primary completion date: Jan 2019 to Jan 2030

    Completion date: Jan 2020 to Jan 2030

    Study Statusv16

  5. Minor

    7 amendments

    7 re-verifications since 2014-11-27, no change to tracked fields

    v9-v15

Show 7 earlier versions

  1. Minor

    Study Status, Outcome Measures

    v8

  2. Minor

    Study Status

    Re-verified, no change to tracked fields

    v7

  3. Notable

    Primary completion date: Jan 2013 to Jan 2019

    Completion date: Jan 2014 to Jan 2020

    Study Statusv6

  4. Minor

    Primary completion date: Jan 2013

    Completion date: Jan 2014; Eligibility criteria revised; Study description shortened, about 1 word; and 1 more

    Show all 5 changes in this update
    • Minor Primary completion date: Jan 2013
    • Minor Completion date: Jan 2014
    • Minor Eligibility criteria revised
      Show what changed
      [...] e study Exclusion Criteria: Patients without competence for concentconsent.
    • Minor Study description shortened, about 1 word
      Show what changed
      Norway is both social, genetically and culturally a homogenoushomogeneous society. The health service is public and has a nearly tota [...] in each center include bipolar patients systematically and are performingperform the patient evaluation as part of their clinical duties. In [...]
    • Minor Site contact updated

    Study Status, Sponsor/Collaborators, Study Description, Study Design, Eligibility, Contacts/Locationsv5

  5. Minor

    3 amendments

    3 re-verifications since 2006-07-24, no change to tracked fields

    v2-v4

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
To describe the broad spectrum of Bipolar Disorder patients admitted to out-patient and in-patient psychiatric departments in Norway. Include all admitted Bipolar patients both with and without co-morbid disorders.
Trial Details
NCT Number NCT00201526
Lead Sponsor Norwegian University of Science and Technology
Collaborators: University of Oslo
Conditions Bipolar Disorder
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov