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SEQUEL: A Non-interventional Naturalistic Project to Investigate the Effect of the Use of SMS Text Service on Treatment Adherence in Patients Treated With Seroquel® (Quetiapine)

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00533260
Collaborator
(none)
128
Enrollment
35
Locations
9
Duration (Months)
3.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The basic hypothesis of this trial is that forgetfulness and failure to establish a routine that facilitates medication adherence are prominent reasons for non-adherence. Daily use of the SMS text messages is designed to enhance patient adherence with medication by promoting daily routine and demonstrate the feasibility of using SMS technology within normal clinical practice in The Netherlands.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    128 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Non-interventional Naturalistic Project to Investigate the Effect of the Use of SMS Text Service on Treatment Adherence in Patients Treated With Seroquel®
    Study Start Date :
    Jul 1, 2007
    Actual Primary Completion Date :
    Apr 1, 2008
    Actual Study Completion Date :
    Apr 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • The subjects should be considered eligible for this trail according to the physician:

      1. Patients with a diagnose of schizophrenia or bipolar disorder with a recent manic episode

      2. Patients who are being treated with quetiapine and are on an effective dose according to the Core Data Sheet; for schizophrenia between 300 and 450 mg (maximum 750 mg) and bipolar disorder between 400 and 800 mg.

      3. Patients who consent to make the coded data available to AstraZeneca; provision of written informed consent

      4. Considered eligible for this study and able to understand and comply with the requirements of the study according to the physician

      5. In possession of a private mobile phone and capable of using this mobile phone to send SMS text messages

      Exclusion Criteria:
      • Subjects who, in the opinion of the Physician, pose an imminent risk of suicide or a danger to themselves or others are excluded from the trial.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Research Site Almelo Netherlands
      2 Research Site Alphen Aan De Rigjn Netherlands
      3 Research Site Amersfoort Netherlands
      4 Research Site Amstelveen Netherlands
      5 Research Site Arnhem Netherlands
      6 Research Site Bennebroek Netherlands
      7 Research Site Beverwijk Netherlands
      8 Research Site Bosch en Duin Netherlands
      9 Research Site Brummen Netherlands
      10 Research Site Brunsum Netherlands
      11 Research Site Doetichem Netherlands
      12 Research Site Druten Netherlands
      13 Research Site Ede Netherlands
      14 Research Site Groningen Netherlands
      15 Research Site Haarlem Netherlands
      16 Research Site Heerde Netherlands
      17 Research Site Helmond Netherlands
      18 Research Site Hoofddorp Netherlands
      19 Research Site Ijmuiden Netherlands
      20 Research Site Leeuwarden Netherlands
      21 Research Site Maastricht Netherlands
      22 Research Site Nijbroek Netherlands
      23 Research Site Nijmegen Netherlands
      24 Research Site Oegstgeest Netherlands
      25 Research Site Raalte Netherlands
      26 Research Site Roermond Netherlands
      27 Research Site Schagen Netherlands
      28 Research Site Steenwijk Netherlands
      29 Research Site Tiel Netherlands
      30 Research Site Tilburg Netherlands
      31 Research Site Venray Netherlands
      32 Research Site Vlaardingen Netherlands
      33 Research Site Voorhout Netherlands
      34 Research Site Weert Netherlands
      35 Research Site Wolfheze Netherlands

      Sponsors and Collaborators

      • AstraZeneca

      Investigators

      • Study Director: N van Schayk, AstraZeneca

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00533260
      Other Study ID Numbers:
      • NIS-NNL-SER-2007/1
      First Posted:
      Sep 21, 2007
      Last Update Posted:
      Dec 9, 2010
      Last Verified:
      Dec 1, 2010
      Keywords provided by , ,
      Patients with a manic episode or patients diagnosed with schizophrenia , patients who are being treated with quetiapine and are on a stable dosing regime
      Additional relevant MeSH terms:
      Schizophrenia
      Bipolar Disorder

      Study Results

      No Results Posted as of Dec 9, 2010