Schizophrenia Clinical Trial
— SEQUELOfficial 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®
| Verified date | December 2010 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Not required for this study: |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 128 |
| Est. completion date | April 2008 |
| Est. primary completion date | April 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Netherlands,
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