- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00533260
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)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Almelo, Netherlands
- Research Site
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Alphen Aan De Rigjn, Netherlands
- Research Site
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Amersfoort, Netherlands
- Research Site
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Amstelveen, Netherlands
- Research Site
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Arnhem, Netherlands
- Research Site
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Bennebroek, Netherlands
- Research Site
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Beverwijk, Netherlands
- Research Site
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Bosch en Duin, Netherlands
- Research Site
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Brummen, Netherlands
- Research Site
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Brunsum, Netherlands
- Research Site
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Doetichem, Netherlands
- Research Site
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Druten, Netherlands
- Research Site
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Ede, Netherlands
- Research Site
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Groningen, Netherlands
- Research Site
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Haarlem, Netherlands
- Research Site
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Heerde, Netherlands
- Research Site
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Helmond, Netherlands
- Research Site
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Hoofddorp, Netherlands
- Research Site
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Ijmuiden, Netherlands
- Research Site
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Leeuwarden, Netherlands
- Research Site
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Maastricht, Netherlands
- Research Site
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Nijbroek, Netherlands
- Research Site
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Nijmegen, Netherlands
- Research Site
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Oegstgeest, Netherlands
- Research Site
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Raalte, Netherlands
- Research Site
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Roermond, Netherlands
- Research Site
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Schagen, Netherlands
- Research Site
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Steenwijk, Netherlands
- Research Site
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Tiel, Netherlands
- Research Site
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Tilburg, Netherlands
- Research Site
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Venray, Netherlands
- Research Site
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Vlaardingen, Netherlands
- Research Site
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Voorhout, Netherlands
- Research Site
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Weert, Netherlands
- Research Site
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Wolfheze, Netherlands
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
The subjects should be considered eligible for this trail according to the physician:
- Patients with a diagnose of schizophrenia or bipolar disorder with a recent manic episode
- 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.
- Patients who consent to make the coded data available to AstraZeneca; provision of written informed consent
- Considered eligible for this study and able to understand and comply with the requirements of the study according to the physician
- 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.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Study Director: N van Schayk, AstraZeneca
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-NNL-SER-2007/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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