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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) (SEQUEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00533260
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : December 9, 2010
Information provided by:

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
Bipolar Disorder Schizophrenia

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 : July 2007
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533260

Research Site
Almelo, Netherlands
Research Site
Alphen Aan De Rigjn, Netherlands
Research Site
Amersfoort, Netherlands
Research Site
Amstelveen, Netherlands
Research Site
Arnhem, Netherlands
Research Site
Bennebroek, Netherlands
Research Site
Beverwijk, Netherlands
Research Site
Bosch en Duin, Netherlands
Research Site
Brummen, Netherlands
Research Site
Brunsum, Netherlands
Research Site
Doetichem, Netherlands
Research Site
Druten, Netherlands
Research Site
Ede, Netherlands
Research Site
Groningen, Netherlands
Research Site
Haarlem, Netherlands
Research Site
Heerde, Netherlands
Research Site
Helmond, Netherlands
Research Site
Hoofddorp, Netherlands
Research Site
Ijmuiden, Netherlands
Research Site
Leeuwarden, Netherlands
Research Site
Maastricht, Netherlands
Research Site
Nijbroek, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Oegstgeest, Netherlands
Research Site
Raalte, Netherlands
Research Site
Roermond, Netherlands
Research Site
Schagen, Netherlands
Research Site
Steenwijk, Netherlands
Research Site
Tiel, Netherlands
Research Site
Tilburg, Netherlands
Research Site
Venray, Netherlands
Research Site
Vlaardingen, Netherlands
Research Site
Voorhout, Netherlands
Research Site
Weert, Netherlands
Research Site
Wolfheze, Netherlands
Sponsors and Collaborators
Study Director: N van Schayk AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00533260     History of Changes
Other Study ID Numbers: NIS-NNL-SER-2007/1
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
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:
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs