Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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)

ClinicalTrials.gov ID

NCT00227305

Acronym / sponsor ID

ANCHOR 150 / D1441C00150

Conditions

Schizophrenia, Bipolar I Disorder

Keywords

Schizophrenia, Bipolar I Disorder

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

381 participants (actual)

Lead sponsor

AstraZenecaIndustry (pharma, biotech, devices)

Study start

Aug 2004

Primary completion

Dec 2007 (actual)

Study completion

Dec 2007 (actual)

First posted

28 Sep 2005 (estimated)

Results

Posted 5 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Who may qualify

Ages

10 to 17 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Incidence and Nature of Adverse Events (AEs)

   Time frame: from open label to week 26+ 30 days

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

2. Number of Patients Withdrawn Due to AEs.

   Time frame: during 26 weeks of treatment

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

3. Changes in Laboratory Test Results (Prolactin)

   Time frame: Duration of study participation

   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.

4. Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score

   Time frame: OL baseline to week 26

   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.

5. Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score

   Time frame: 26 weeks of treatment

   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.

6. Change From Baseline in Weight

   Time frame: 26 weeks of treatment

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

7. Change From Baseline in Supine Pulse

   Time frame: OL baseline to week 26

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

8. Change From OL Baseline in Supine Systolic BP.

   Time frame: OL baseline to Week 26

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

9. Change From OL Baseline in Supine Diastolic BP.

   Time frame: OL baseline to Week 26

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

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 24024534Findling RL, Pathak S, Earley WR, Liu S, DelBello M. Safety, tolerability, and efficacy of quetiapine in youth with schizophrenia or bipolar I disorder: a 26-week, open-label, continuation study. J Child Adolesc Psychopharmacol. 2013 Sep;23(7):490-501. doi: 10.1089/cap.2012.0092. Epub 2013 Sep 11.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

48 sites in 9 countries: see every site and its status.