Mania
+1
Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect
Sponsored by AstraZeneca
About this trial
Last updated 13 years ago
Study ID
NIS-NNL-SER-2005/1
Status
Completed
Type
Observational
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 18 years ago
What is this trial about?
With this observational study we want to examine if the intensity of agitation, the
intensity of psychotic symptoms and the presence of sleeping disorder predict the success
of the treatment with a atypical antipsychotic after 12 weeks of treatment with patients
with a psychotic and/or manic episode. In this study it will be examined what the
percentage of patients with a 2-point improvement at the CGI-scale is. Of these group,
the responders, retrospective the profile of the responders will be analysed (key-factors
and confounders).
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR
designation was changed to XR after consultation with FDA.
What are the participation requirements?
Inclusion Criteria
- Patients with a manic episode or patients diagnosed with schizophrenia (psychotic episode)
- Patients who start a treatment with an atypical antipsychotic : quetiapine, olanzapine or risperidone
- Patients who are prepared to consent to make the coded data available to AstraZeneca
- Patients with a CGI ≥ 4
Exclusion Criteria
- Patients with a serious underlying disease (including renal or hepatic insufficiency, cancer, cardiovascular diseases and suchlike).
- Contra-indications for quetiapine, olanzapine or risperidone according to the SmPC for these products
- Patients unable to give informed consent according to the attending physician