Fast Titration Of Quetiapine Versus Currently Approved Titration
1 other identifier
interventional
150
1 country
7
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of a more rapid dose titration in acute schizophrenic patients compared to the conventional titration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2004
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 15, 2005
CompletedFirst Posted
Study publicly available on registry
November 17, 2005
CompletedJanuary 26, 2011
January 1, 2011
November 15, 2005
January 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with moderate and severe adverse events
Secondary Outcomes (1)
Mean daily level of somnolence and orthostatic dizziness as rated on AE intensity scale
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent, male or female between 18 and 60 years old, having acute exacerbation of their schizophrenia or schizoaffective disorder requiring admission to hospital. Should stay in hospital for at least 7 days.
You may not qualify if:
- Patients treated with Risperdal consta or Clozapine last 28 days, pregnancy or breast-feeding, patients known to be intolerant or unresponsive to quetiapine, known arrhythmia, other serious medical conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (7)
Research Site
Arendal, Norway
Research Site
Ålesund, Norway
Research Site
Klepp stasjon, Norway
Research Site
Kristiansand, Norway
Research Site
Nesttun, Norway
Research Site
Oslo, Norway
Research Site
Ottestad, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Norway Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 15, 2005
First Posted
November 17, 2005
Study Start
October 1, 2004
Study Completion
September 1, 2005
Last Updated
January 26, 2011
Record last verified: 2011-01