NCT00305422

Brief Summary

The purpose of the study is to investigate the outcome on negative symptoms of schizophrenic patients during therapy with quetiapine or risperidone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Nov 2001

Shorter than P25 for phase_3 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

November 1, 2001

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

First QC Date

March 20, 2006

Last Update Submit

June 9, 2009

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Clinical efficacy of both neuroleptics, especially with regard to cognitive deficits and functional brain activation between baseline and week 12

Secondary Outcomes (1)

  • Change from baseline in PANSS negative symptom total score, PANSS subscores, CGI, CGI-severity of illness, HAMD, Simpson-Angus-Scale, BPRS, specific PANSS items , Startle reflex.

Interventions

Quetiapine fumarateDRUG
RisperidoneDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • men and women aged 18 to 65 years with diagnosis of schizophrenia
  • score of at least 4 CGI, PANSS negative subscale score \> 21

You may not qualify if:

  • Substance or alcohol dependence
  • female patients who are pregnant, lactating or at risk of pregnancy
  • history of organic CNS-trauma, epilepsy, meningoencephalitis, psychosurgery, instable somatic conditions
  • risk of suicide or aggressive behaviour
  • history of electroconvulsive therapy, Parkinson's disease, Prolactin-dependent tumor
  • existence of metal in the body as by cardiac pacemaker, coil, total prosthesis, metal splinter, metal articulation, metal balls.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Munich, Germany

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 Germany Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 20, 2006

First Posted

March 22, 2006

Study Start

November 1, 2001

Study Completion

January 1, 2003

Last Updated

June 11, 2009

Record last verified: 2009-06

Locations

DE(1)