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OpenTrials
Completed

NCT Number: NCT00305422

Effect of Quetiapine on Negative Symptoms and Cognition

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site

Munich, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • fulfil the criterion to be right-handed for inclusion in the fMRI investigations

Exclusion criteria

  • 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

For the subset of subjects for the fMRI investigations the following additional exclusion criteria is valid as:

  • existence of metal in the body as by cardiac pacemaker, coil, total prosthesis, metal splinter, metal articulation, metal balls.

Treatment and study plan

Quetiapine fumarate

Drug

Risperidone

Drug

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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Efficacy of Quetiapine Compared to Risperidone on Negative Symptoms and Cognition With Regard to Underlying Neurobiological Mechanisms and Brain Activation.

Important dates

Study start
2001
Study completion
2003
First posted
Mar 22, 2006
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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