Clinical trial NCT00649064: A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs
Official title: A Multi-Center Study To Examine The Clinical Effects Of Cross Titration Of Antipsychotics With Ziprasidone In Subjects With Schizophrenia Or Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizoaffective Disorder
Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if differences exist in outcome in patients with schizophrenia or schizoaffective disorder who were switched from other antipsychotics to ziprasidone.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* Outpatients for at least 3 months on treatment with sulpiride, olanzapine, quetiapine, or risperidone and at least a partial beneficial response to typical antipsychotic treatment including for the current episode
* Partial improvement in symptoms that justified a switch to ziprasidone

Exclusion Criteria:

* Diagnosis of major depression or occurrence of moderate depressive symptoms
* Resistance to conventional antipsychotic drugs
* Treatment with other drugs such as antiseizure medications, antipsychotics, antidepressants, or mood stabilizing agents that might interfere with the assessement of the efficacy of ziprasidone

Primary outcomes:
measure: Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score
timeFrame: Week 6
Secondary outcomes:
measure: Adverse events
timeFrame: Weeks 1, 2, and 6
measure: Change from baseline in weight
timeFrame: Baseline and Week 6
measure: Change from baseline in prolactin and lipid levels
timeFrame: Baseline and Week 6
measure: Change from baseline in electrocardiogram
timeFrame: Baseline and Week 6
measure: Change from baseline in Positive and Negative Symptom Scale (PANSS), including PANSS total scores and PANSS positive, PANSS negative, and PANSS general subscale scores
timeFrame: Baseline and Weeks 1, 2, and 6
measure: Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores
timeFrame: Baseline and Weeks 1, 2, and 6
measure: Clinical Global Impressions-Improvement (CGI-I) scale scores
timeFrame: Baseline (using historical data) and Weeks 1, 2, and 6
measure: Change from baseline in movement disorder rating scales, including Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS)
timeFrame: Baseline and Week 6
measure: Change from baseline in vital signs
timeFrame: Baseline and Weeks 1, 2, and 6
measure: Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: