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OpenTrials
Completed

NCT Number: NCT00254787

Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients

The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme with to the current approved label titration.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women age ≥18 to ≤65 years with acute schizophrenia
  • Provision of written informed consent prior to enrolment

Exclusion criteria

  • Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder or mental retardation
  • Patients with substance dependence
  • Female patients who are pregnant, lactating or at risk of pregnancy

Treatment and study plan

IR (Immediate-Release) quetiapine fumarate (drug)

Drug

Primary outcomes

  1. Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment

Secondary outcomes

  1. Safety and Tolerability

  2. Number and type of adverse events

  3. Changes in vital signs and weight

  4. Clinically significant changes in ECG (reported as AE)

  5. Change of Simpson-Angus Scale (SAS) score

  6. Change of Barnes Akathisia Rating Scale (BARS) score

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in the Treatment of Patients With Acute Schizophrenia - a Multicentre, Double-Blind, Parallel Group, Randomized Study

Important dates

Study start
2005
Study completion
2006
First posted
Nov 17, 2005
Registry last updated
Jun 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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