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)

Completed

• Conditions: Bipolar Disorder; Schizophrenia

• Registration Number: NCT00533260
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-09-20
• Study First Submitted QC: 2007-09-20
• Study First Posted: 2007-09-21
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Research Site; 🇳🇱 Wolfheze, Netherlands