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Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone

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Viatris

Status and phase

Completed
Phase 4

Conditions

Schizophrenia
Schizoaffective Disorder

Treatments

Drug: ziprasidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00406315
A1281148

Details and patient eligibility

About

The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.

Enrollment

255 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males or females, between 18 and 55 years of age, at the time of consent.
  • Subjects must have a primary diagnosis of schizophrenia, any subtype (code 295.xx), or schizoaffective disorder as defined in DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition)
  • Subjects must have normal vital signs, physical examination, ECG, and laboratory findings except for minor deviations determined and documented to be clinically insignificant by the investigator or a sub-investigator who is a medical doctor.

Exclusion criteria

  • Subjects who are unable to provide informed consent
  • Subjects who meet criteria for a DSM-IV-TR Axis I (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) diagnosis other than schizophrenia or schizoaffective disorder, including psychoactive substance abuse or dependence within one year of study entry
  • Females who are pregnant, breast feeding, or lactating at screening.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

255 participants in 1 patient group

A1
Other group
Description:
atypical antipsychotic for the treatment of schizophrenia
Treatment:
Drug: ziprasidone

Trial contacts and locations

40

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Data sourced from clinicaltrials.gov

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