Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT00533260
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00533260
Study Brief:
Protocol Section:
NCT00533260