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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Quetiapine Fumarate (SEROQUEL) in the treatment of Adolescent Patients with Schizophrenia and Bipolar I Disorder

Research Site

A 26-week, Multicenter, Open-label Phase 3b Study of the Safety and Tolerability of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in Daily Doses of 400 mg to 800 mg in Children and Adolescents with Bipolar I Disorder and Adolescents with Schizophrenia (abbreviated)

Number of participants that had AE which occurred from first dose date to last dose date + 30 days.

Number of subjects who withdrew from the study due to AEs.

Clinical important shift to high prolactin from open-label (OL) baseline to week 26.

High Prolactin is defined as value >26 ug/L for female and value >20 ug/L for male.

Number of patients for who the total score is estimated as worse. The Simpson Angus Scale (SAS)is used to assess Parkinsonian symptoms (a type of movement disorders). The score was calculated as the sum of the 10 individual item scores.  Total Score ranges from 0-40 (normal to worse). Individual item scale range from 0 to 4 (normal to worse). 
Improved define as those with a <= -1 change in SAS total score.
Worsened defined as those with a >=1 change in SAS total score.

Number of patients for who the total score is estimated as worse. The Barnes Akathisia Rating Scale (BARS) global score is used to measure Akathisia (a type of movement disorders). BARS is the  item 4 score from the BARS assessment.  The scale is from a range 0-5 (normal to worse). Change from baseline in BARS global score increase means worse.
Improved defined as those with a <= -1 change in BARS global score.
Worsened defined as those with a >= 1 change in BARS global score.

Number with 7% or more increase (without adjustment for normal growth)

Change from OL baseline to week 26 in supine pulse (bpm)

Changes from OL baseline to the final visits in Supine systolic BP (mmHg)

Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)

Age, Customized

Gender, Male/Female

Diagnosis

Study Specific Characteristic

No comparator group, open label treatment, duration only 26 weeks - not long enough to assess full impact on growth and development

Incidence and nature of adverse events (AEs)

Number of patients withdrawn due to AEs.

Changes in laboratory test results (Prolactin)

Category shift in Tanner stage. Number of subjects who experienced the change is presented.
Tanner stages (I-V) was used to characterize physical development in children, adolescents, and adults.  The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.

Number of patients with Tanner stagging data at OL baseline and week 26 (final visit)

Changes in Tanner stage

Children's Global Assessment Scale (CGAS) is used to rate the general functioning of children under the age of 18. It is the 100-point single-item score that was collected in the Clinical Report Form (CRF), scored from 0-100 (worse to normal).

Number of patients with CGAS score at OL baseline and week 26.

Change from baseline in Children's Global Assessment Scale (CGAS) score

Number of patients with SAS score at OL baseline and week 26.

Categorical Change from OL baseline to week 26 in Simpson-Angus Scale (SAS)total score

Number of patients with BARS score at OL baseline and week 26.

Categorical Change from baseline in Barnes Akathisia Rating Scale (BARS) global score

Number of participants is based on patients with both baseline values and post-baseline values.

Change from baseline in weight

Number of participants with OL baseline and post treatment visits

Change from baseline in supine pulse

Change from OL baseline in supine systolic BP.

Change from OL baseline in supine diastolic BP.

Overall Study

Required to have completed one feeder study, either bipolar mania study D1441C00149 or schizophrenia study D1441C00112 and be willing to participate in a 26 week open label study and be between the ages of 10 and 18 years at the time of consent for this study, initial titration to maintain blind in feeder study

Quetiapine Fumarate (SEROQUEL) in the treatment of Adolescent Patients with Schizophrenia and Bipolar I Disorder - ANCHOR 150

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=256&filename=CSR-D1441C00150.pdf

CSR-D1441C00150.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator