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OpenTrials
Completed

NCT Number: NCT00254241

Safety and Efficacy of Seroquel in First Episode Schizophrenia

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

Completed

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Seroquel and Risperidone

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2002
Study completion
2006
First posted
Nov 16, 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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