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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)
This study is currently recruiting participants.
Verified by AstraZeneca, December 2008
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00533260
  Purpose

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
Bipolar Disorder
Schizophrenia

MedlinePlus related topics: Bipolar Disorder Schizophrenia
Drug Information available for: Quetiapine Quetiapine fumarate
U.S. FDA Resources
Study Type: Observational
Study Design: 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®

Further study details as provided by AstraZeneca:

Estimated Enrollment: 100
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533260

Contacts
Contact: AstraZeneca The Netherlands Clinical Research CNS, Clincial Study Information +31 79 363 2198 nathalie.vanSchayk@astrazeneca.com

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

Study ID Numbers: D1443000000
Study First Received: September 20, 2007
Last Updated: December 19, 2008
ClinicalTrials.gov Identifier: NCT00533260  
Health Authority: Not required for this study:

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

Study placed in the following topic categories:
Schizophrenia
Quetiapine
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009