Clinical trial NCT00137020: Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective Disorder
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: Schizophrenia
Psychotic Disorders
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 294
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 primary objective is to compare effectiveness of ziprasidone treatment to current treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric Rating Scale (BPRS) scores versus baseline


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of schizophrenia or schizoaffective disorder, using DSM-IV criteria.
* Currently receiving either haloperidol, olanzapine or risperidone within -/+ 25% of the recommended daily dose (as delineated by the medication's package insert

Exclusion Criteria:

* Resistance to conventional antipsychotic drugs
* With antipsychotic agents other than olanzapine, risperidone or haloperidol at start of treatment regimen within 12 hours prior to first dose of study drug

Primary outcomes:
measure: The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score
Secondary outcomes:
measure: Change From Baseline In Clinical Global Impression Severity (CGI-S)
measure: Clinical Global Impression Improvement (CGI-I)
measure: Change From Baseline In Positive and Negative Syndrome Scale (PANSS) Total
measure: Change from baseline in scores on the Montgomery-Asberg Depression Rating Scale (MADRS)
measure: Change from baseline in scores on the MADRS Without Items 4, 5
measure: Change from baseline in Global Assessment of Functioning (GAF)
measure: Change From Baseline In Drug Attitude Inventory (DAI)
measure: Change From Baseline In Weight
measure: Change From Baseline In Prolactin And Lipid Levels
measure: Change From Baseline in Modified Simpson Angus Scale (m-SAS) Total Score
measure: Change From Baseline in Barnes Akathisia Scale (BAS)
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Movement Ratings Total Score
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Global Judgment Of Severity Total Score
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Pfizer Investigational Site
city: Assiut
country: Egypt
facility: Pfizer Investigational Site
city: Cairo
country: Egypt
facility: Pfizer Investigational Site
city: Tanta
country: Egypt
facility: Pfizer Investigational Site
city: Larissa
country: Greece
facility: Pfizer Investigational Site
state: Mezourlo
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Jordan
country: Jordan
facility: Pfizer Investigational Site
city: Kuwait
country: Kuwait
facility: Pfizer Investigational Site
city: Beirut
country: Lebanon
facility: Pfizer Investigational Site
city: Khobar
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Garankuwa
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Krugersdorp
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Noordheuwel, Krugersdorp
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Bellair, Durban
country: South Africa
facility: Pfizer Investigational Site
state: Kwa-Zulu Natal
city: Pinetown, Durban
country: South Africa
facility: Pfizer Investigational Site
state: Kwa-Zulu Natal
city: Observatory, Cape Town
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Bursa
country: Turkey
facility: Pfizer Investigational Site
city: Erzurum
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Manisa
country: Turkey
facility: Pfizer Investigational Site
city: Sisli
country: Turkey
facility: Pfizer Investigational Site
city: Dubai
country: United Arab Emirates
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: