CClinicalTrials.gg
CompletedNCT00533260SEQUELUpdated Dec 9, 2010

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)

An observational study in Bipolar Disorder and Schizophrenia, sponsored by AstraZeneca. Completed at 35 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-09.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
128
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bipolar Disorder
  • Schizophrenia

Keywords

  • Patients with a manic episode or patients diagnosed with schizophrenia , patients who are being treated with quetiapine and are on a stable dosing regime
03

In context

Schizophrenia

3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's enrollment of 128 is below the median of 178 across 491 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
128 participants (actual)
06

Study locations

35 sites
  • 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
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00533260
Lead sponsor
AstraZeneca
First posted
Sep 21, 2007
Start date
Jul 2007
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Dec 9, 2010

Study contacts

N van Schayk
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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