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) (SEQUEL)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00533260
First received: September 20, 2007
Last updated: December 7, 2010
Last verified: December 2010

September 20, 2007
December 7, 2010
July 2007
April 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00533260 on ClinicalTrials.gov Archive Site
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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)
A Non-interventional Naturalistic Project to Investigate the Effect of the Use of SMS Text Service on Treatment Adherence in Patients Treated With Seroquel®

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

The patients who were considered for participation were patients who were being treated with quetiapine according to the Core Data Sheet and who were on a stable dosing regime. They could have been patients with schizophrenia or patients experiencing a manic episode associated with a bipolar disorder. Quetiapine was administered to the patients in regular practice.

  • Bipolar Disorder
  • Schizophrenia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
April 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00533260
NIS-NNL-SER-2007/1
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AstraZeneca
AstraZeneca
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Study Director: N van Schayk AstraZeneca
AstraZeneca
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP