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)

AstraZeneca

Status: Completed

Conditions: Schizophrenia; Bipolar Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT00533260

NIS-NNL-SER-2007/1

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.