NCT00254241

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started May 2002

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

First QC Date

November 14, 2005

Last Update Submit

June 9, 2009

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

  • CGI severity of illness

  • CGI global improvement

  • PANSS total score and subscales)

  • Abnormal Involuntary Movement Scale (AIMS)

  • Dose of anti cholinergic medication

  • +3 more secondary outcomes

Interventions

Seroquel and RisperidoneDRUG

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Quetiapine FumarateRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • AstraZeneca Seroquel Medical Science Director, MD

    AstraZenenca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 14, 2005

First Posted

November 16, 2005

Study Start

May 1, 2002

Study Completion

June 1, 2006

Last Updated

June 11, 2009

Record last verified: 2009-06

Locations

GB(1)