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
1 other identifier
observational
128
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2007
Shorter than P25 for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 20, 2007
CompletedFirst Posted
Study publicly available on registry
September 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedDecember 9, 2010
December 1, 2010
9 months
September 20, 2007
December 7, 2010
Conditions
Keywords
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (35)
Research Site
Almelo, Netherlands
Research Site
Alphen Aan de Rigjn, Netherlands
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Amersfoort, Netherlands
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Amstelveen, Netherlands
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Arnhem, Netherlands
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Bennebroek, Netherlands
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Beverwijk, Netherlands
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Bosch en Duin, Netherlands
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Brummen, Netherlands
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Brunssum, Netherlands
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Doetichem, Netherlands
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Druten, Netherlands
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Ede, Netherlands
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Groningen, Netherlands
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Haarlem, Netherlands
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Heerde, Netherlands
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Helmond, Netherlands
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Hoofddorp, Netherlands
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IJmuiden, Netherlands
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Leeuwarden, Netherlands
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Maastricht, Netherlands
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Nijbroek, Netherlands
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Nijmegen, Netherlands
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Oegstgeest, Netherlands
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Raalte, Netherlands
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Roermond, Netherlands
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Schagen, Netherlands
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Steenwijk, Netherlands
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Tiel, Netherlands
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Tilburg, Netherlands
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Venray, Netherlands
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Vlaardingen, Netherlands
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Voorhout, Netherlands
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Weert, Netherlands
Research Site
Wolfheze, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
N van Schayk
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 20, 2007
First Posted
September 21, 2007
Study Start
July 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
December 9, 2010
Record last verified: 2010-12