Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective Disorder

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00137020

Collaborator

(none)

294

Enrollment

Locations

Duration (Months)

10.9

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Psychotic Disorders	Drug: ziprasidone	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2004

Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score []

Secondary Outcome Measures

Change From Baseline In Clinical Global Impression Severity (CGI-S) []
Clinical Global Impression Improvement (CGI-I) []
Change From Baseline In Positive and Negative Syndrome Scale (PANSS) Total []
Change from baseline in scores on the Montgomery-Asberg Depression Rating Scale (MADRS) []
Change from baseline in scores on the MADRS Without Items 4, 5 []
Change from baseline in Global Assessment of Functioning (GAF) []
Change From Baseline In Drug Attitude Inventory (DAI) []
Change From Baseline In Weight []
Change From Baseline In Prolactin And Lipid Levels []
Change From Baseline in Modified Simpson Angus Scale (m-SAS) Total Score []
Change From Baseline in Barnes Akathisia Scale (BAS) []
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Movement Ratings Total Score []
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Global Judgment Of Severity Total Score []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Alexandria		Egypt
2	Pfizer Investigational Site	Assiut		Egypt
3	Pfizer Investigational Site	Cairo		Egypt
4	Pfizer Investigational Site	Tanta		Egypt
5	Pfizer Investigational Site	Larissa	Mezourlo	Greece	41110
6	Pfizer Investigational Site	Athens		Greece	11528
7	Pfizer Investigational Site	Athens		Greece	12462
8	Pfizer Investigational Site	Athens		Greece	15126
9	Pfizer Investigational Site	Jordan		Jordan
10	Pfizer Investigational Site	Kuwait		Kuwait	13041
11	Pfizer Investigational Site	Beirut		Lebanon
12	Pfizer Investigational Site	Khobar		Saudi Arabia	31451
13	Pfizer Investigational Site	Garankuwa	Gauteng	South Africa	0208
14	Pfizer Investigational Site	Krugersdorp	Gauteng	South Africa	1739
15	Pfizer Investigational Site	Noordheuwel, Krugersdorp	Gauteng	South Africa	1739
16	Pfizer Investigational Site	Bellair, Durban	Kwa-Zulu Natal	South Africa	4094
17	Pfizer Investigational Site	Pinetown, Durban	Kwa-Zulu Natal	South Africa	3600
18	Pfizer Investigational Site	Observatory, Cape Town	Western Cape	South Africa	7925
19	Pfizer Investigational Site	Ankara		Turkey
20	Pfizer Investigational Site	Bursa		Turkey
21	Pfizer Investigational Site	Erzurum		Turkey
22	Pfizer Investigational Site	Istanbul		Turkey
23	Pfizer Investigational Site	Izmir		Turkey	35340
24	Pfizer Investigational Site	Izmir		Turkey
25	Pfizer Investigational Site	Manisa		Turkey
26	Pfizer Investigational Site	Sisli		Turkey
27	Pfizer Investigational Site	Dubai		United Arab Emirates