Phase 3
Completed N=381
Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder
Source: ClinicalTrials.gov NCT00227305 ↗Enrolled (actual)
381
Serious AEs
12.1%
Results posted
Oct 2012
Primary outcomePrimary: Incidence and Nature of Adverse Events (AEs) — 321 Participants
Summary
The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Nature of Adverse Events (AEs) |
321 | — |
| PRIMARY Number of Patients Withdrawn Due to AEs. |
37 | — |
| PRIMARY Changes in Laboratory Test Results (Prolactin) |
19 | — |
| PRIMARY Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score |
34 | — |
| PRIMARY Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score |
11 | — |
| PRIMARY Change From Baseline in Weight |
134 | — |
| PRIMARY Change From Baseline in Supine Pulse |
0.8 | — |
| PRIMARY Change From OL Baseline in Supine Systolic BP. |
1.7 | — |
| PRIMARY Change From OL Baseline in Supine Diastolic BP. |
1.3 | — |
| SECONDARY Changes in Tanner Stage |
70 | — |
| SECONDARY Change From Baseline in Children's Global Assessment Scale (CGAS) Score |
7 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is able to provide written assent and the parents or legal guardian of the patient are/is able to provide written informed consent before beginning any study related procedures
- Patient previously enrolled in either double-blind Study D1441C00149 or D1441C00112
- Patient has documented clinical diagnosis of schizophrenia or bipolar I disorder
- Patient's parent or legal guardian will be able to accompany the patient to each scheduled study visit
Exclusion Criteria
- Patients (female) must not be pregnant or lactating
- Patients with a known intolerance or lack of response to previous treatment with quetiapine
- Patients who have previously participated in this study
Data sourced from ClinicalTrials.gov (NCT00227305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.