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 has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00533260
First received: September 20, 2007
Last updated: December 7, 2010
Last verified: December 2010
  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

Study Type: Observational
Study Design: 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®

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Enrollment: 128
Study Start Date: July 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
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
AstraZeneca
Investigators
Study Director: N van Schayk AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00533260     History of Changes
Other Study ID Numbers: NIS-NNL-SER-2007/1
Study First Received: September 20, 2007
Last Updated: December 7, 2010
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

Additional relevant MeSH terms:
Schizophrenia
Bipolar Disorder
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Affective Disorders, Psychotic
Mood Disorders

ClinicalTrials.gov processed this record on October 01, 2014