Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective Disorder
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137020
First received: August 26, 2005
Last updated: August 11, 2006
Last verified: August 2006
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Schizophrenia Psychotic Disorders |
Drug: ziprasidone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
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
| Estimated Enrollment: | 294 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | April 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137020
Locations
| Egypt | |
| Pfizer Investigational Site | |
| Alexandria, Egypt | |
| Pfizer Investigational Site | |
| Assiut, Egypt | |
| Pfizer Investigational Site | |
| Cairo, Egypt | |
| Pfizer Investigational Site | |
| Tanta, Egypt | |
| Greece | |
| Pfizer Investigational Site | |
| Larissa, Mezourlo, Greece, 41110 | |
| Pfizer Investigational Site | |
| Athens, Greece, 11528 | |
| Pfizer Investigational Site | |
| Athens, Greece, 15126 | |
| Pfizer Investigational Site | |
| Athens, Greece, 12462 | |
| Jordan | |
| Pfizer Investigational Site | |
| Jordan, Jordan | |
| Kuwait | |
| Pfizer Investigational Site | |
| Kuwait, Kuwait, 13041 | |
| Lebanon | |
| Pfizer Investigational Site | |
| Beirut, Lebanon | |
| Saudi Arabia | |
| Pfizer Investigational Site | |
| Khobar, Saudi Arabia, 31451 | |
| South Africa | |
| Pfizer Investigational Site | |
| Garankuwa, Gauteng, South Africa, 0208 | |
| Pfizer Investigational Site | |
| Krugersdorp, Gauteng, South Africa, 1739 | |
| Pfizer Investigational Site | |
| Noordheuwel, Krugersdorp, Gauteng, South Africa, 1739 | |
| Pfizer Investigational Site | |
| Bellair, Durban, Kwa-Zulu Natal, South Africa, 4094 | |
| Pfizer Investigational Site | |
| Pinetown, Durban, Kwa-Zulu Natal, South Africa, 3600 | |
| Pfizer Investigational Site | |
| Observatory, Cape Town, Western Cape, South Africa, 7925 | |
| Turkey | |
| Pfizer Investigational Site | |
| Ankara, Turkey | |
| Pfizer Investigational Site | |
| Bursa, Turkey | |
| Pfizer Investigational Site | |
| Erzurum, Turkey | |
| Pfizer Investigational Site | |
| Istanbul, Turkey | |
| Pfizer Investigational Site | |
| Izmir, Turkey, 35340 | |
| Pfizer Investigational Site | |
| Izmir, Turkey | |
| Pfizer Investigational Site | |
| Manisa, Turkey | |
| Pfizer Investigational Site | |
| Sisli, Turkey | |
| United Arab Emirates | |
| Pfizer Investigational Site | |
| Dubai, United Arab Emirates | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00137020 History of Changes |
| Other Study ID Numbers: | A1281117 |
| Study First Received: | August 26, 2005 |
| Last Updated: | August 11, 2006 |
| Health Authority: | Turkey: Ministry of Health |
Additional relevant MeSH terms:
|
Psychotic Disorders Mental Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Antipsychotic Agents Ziprasidone Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 23, 2013