Safety and Efficacy of Seroquel in First Episode Schizophrenia

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: November 14, 2005
Last updated: June 9, 2009
Last verified: June 2009
To compare the safety, tolerability and efficacy of Seroquel and risperidone in first episode schizophrenia

Condition Intervention Phase
Drug: Seroquel and Risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Seroquel in First Episode Schizophrenia

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The proportion of patients developing clinically significant EPS at any point between baseline (day 1) and final assessment

Secondary Outcome Measures:
  • CGI severity of illness
  • CGI global improvement
  • PANSS total score and subscales)
  • Abnormal Involuntary Movement Scale (AIMS)
  • Dose of anti cholinergic medication
  • Serum prolactin levels
  • Proportion of patients discontinuing treatment due to reasons of lack of efficacy or adverse effects
  • Proportion of patients experiencing relapse.

Estimated Enrollment: 80
Study Start Date: May 2002
Study Completion Date: June 2006

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-35 years Meet ICD-10 criteria for schizophrenia No abnormaility on clinical examination No previous episode of psychosis No previous antipsychotics of any kind in last 3 months

Exclusion Criteria:

  • Have received a course of antipsychotics drug treatment prior to entry which may introduce risk factors or interfere with study procedures Have received anticholinergics within 10 days of baseline aseessment Have received mood stabilizers or anti depressants within 2 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00254241

United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZenenca
  More Information

No publications provided Identifier: NCT00254241     History of Changes
Other Study ID Numbers: BU-5077-0011
Study First Received: November 14, 2005
Last Updated: June 9, 2009
Health Authority: United Kingdom: Department of Health

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on December 01, 2015