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Completed

NCT Number: NCT00428350

Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic

The primary objective of the study is to evaluate the efficacy of quetiapine fumarate (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day 56 using the last observation carried forward (LOCF) method.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of written informed consent for study participation before initiation of any study related procedures, signed by the patient's legal guardian
  • Female and/or male, aged between 18 and 60 years (inclusive)
  • Is hospitalised in a psychiatric unit with an acute episode of schizophrenia defined by CCMD-3 criteria as one of the following: [20.1] paranoid schizophrenia, [20.2] hebephrenic schizophrenia, [20.3] catatonic schizophrenia, [20.5] undifferentiated schizophrenia

Exclusion criteria

  • CCMD-3 diagnosis of mental retardation
  • Psychosis judged to be the direct physiological effect of an abused medication or substance

Treatment and study plan

quetiapine fumarate (Seroquel)

Drug

Primary outcomes

  1. Change from baseline in PANSS total score at Day 56 (LOCF)

Secondary outcomes

  1. Change from baseline in PANSS positive scale score at Day 56 (LOCF)

  2. Change from baseline in PANSS negative scale score at Day 56 (LOCF)

  3. Change from baseline in PANSS EC score at day 56 ,

  4. Change from baseline in MADRS total score at Day 56. etc

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 24-Week, Multi-Centre, Open-Label, Single-Arm, Phase IV Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) With Daily Dose 600mg-750mg as Mono-Therapy in the Treatment of Acute Schizophrenic Patients

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 30, 2007
Registry last updated
Mar 25, 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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