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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)

NCT ID: NCT00533260

Last Updated: 2010-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder Schizophrenia

Keywords

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Patients with a manic episode or patients diagnosed with schizophrenia , patients who are being treated with quetiapine and are on a stable dosing regime

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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N van Schayk

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Almelo, , Netherlands

Site Status

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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

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Wolfheze, , Netherlands

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Countries

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Netherlands

Other Identifiers

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NIS-NNL-SER-2007/1

Identifier Type: -

Identifier Source: org_study_id