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Safety and Efficacy of Seroquel in First Episode Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00254241
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : June 11, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
To compare the safety, tolerability and efficacy of Seroquel and risperidone in first episode schizophrenia

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Seroquel and Risperidone Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Seroquel in First Episode Schizophrenia
Study Start Date : May 2002
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254241


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

ClinicalTrials.gov Identifier: NCT00254241     History of Changes
Other Study ID Numbers: BU-5077-0011
First Posted: November 16, 2005    Key Record Dates
Last Update Posted: June 11, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents