Clinical trial NCT00533260: 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)
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®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Research Site
city: Alphen Aan De Rigjn
country: Netherlands
facility: Research Site
city: Amersfoort
country: Netherlands
facility: Research Site
city: Amstelveen
country: Netherlands
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
city: Bennebroek
country: Netherlands
facility: Research Site
city: Beverwijk
country: Netherlands
facility: Research Site
city: Bosch en Duin
country: Netherlands
facility: Research Site
city: Brummen
country: Netherlands
facility: Research Site
city: Brunsum
country: Netherlands
facility: Research Site
city: Doetichem
country: Netherlands
facility: Research Site
city: Druten
country: Netherlands
facility: Research Site
city: Ede
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Haarlem
country: Netherlands
facility: Research Site
city: Heerde
country: Netherlands
facility: Research Site
city: Helmond
country: Netherlands
facility: Research Site
city: Hoofddorp
country: Netherlands
facility: Research Site
city: Ijmuiden
country: Netherlands
facility: Research Site
city: Leeuwarden
country: Netherlands
facility: Research Site
city: Maastricht
country: Netherlands
facility: Research Site
city: Nijbroek
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Oegstgeest
country: Netherlands
facility: Research Site
city: Raalte
country: Netherlands
facility: Research Site
city: Roermond
country: Netherlands
facility: Research Site
city: Schagen
country: Netherlands
facility: Research Site
city: Steenwijk
country: Netherlands
facility: Research Site
city: Tiel
country: Netherlands
facility: Research Site
city: Tilburg
country: Netherlands
facility: Research Site
city: Venray
country: Netherlands
facility: Research Site
city: Vlaardingen
country: Netherlands
facility: Research Site
city: Voorhout
country: Netherlands
facility: Research Site
city: Weert
country: Netherlands
facility: Research Site
city: Wolfheze
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: N van Schayk
role: STUDY_DIRECTOR
References: