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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00406315
First received: November 29, 2006
Last updated: February 2, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
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 Sixteen-Week, Multi-Center, Open-Label Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone In Subjects Diagnosed With Schizophrenia Or Schizoaffective Disorder

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Weight at Week 16 [ Time Frame: Baseline, Week 16, Week 16 LOCF ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Fasting Glucose at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Fasting Insulin at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Waist and Hip Circumference at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16 [ Time Frame: Baseline, Week 16, Week 16 LOCF ] [ Designated as safety issue: No ]
  • Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16 [ Time Frame: Baseline, Week 16, Week 16 LOCF ] [ Designated as safety issue: No ]
  • Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16 [ Time Frame: Week 16, Week 16 LOCF ] [ Designated as safety issue: No ]
  • Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16 [ Time Frame: Baseline, Week 16, Week 16 LOCF ] [ Designated as safety issue: No ]
  • Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16 [ Time Frame: Baseline, Week 16, Week 16 LOCF ] [ Designated as safety issue: No ]
  • Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16 [ Time Frame: Baseline, Week 16, Week 16 LOCF ] [ Designated as safety issue: No ]
  • Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16 [ Time Frame: Baseline, Week 16, Week 16 LOCF ] [ Designated as safety issue: No ]

Enrollment: 255
Study Start Date: November 2006
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A1
atypical antipsychotic for the treatment of schizophrenia
Drug: ziprasidone
Days 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase
Other Name: Geodon, Zeldox

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406315

  Show 41 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00406315     History of Changes
Other Study ID Numbers: A1281148
Study First Received: November 29, 2006
Results First Received: December 1, 2009
Last Updated: February 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Ziprasidone
Antipsychotic Agents
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 August 27, 2014