High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms

NCT00403546

Last updated date
Study Location
Medical College of Georgia
Augusta, Georgia, 30912, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Schizophrenia or Schizoaffective disorder, any subtype

- Age 18-65 years

- Treated with ziprasidone at a dose of 160 mg/d for at least 3 weeks with adequate compliance

- Concomitant standing or other medications as needed (except other antipsychotics and those noted as contraindicated in the ziprasidone package insert) are permitted during all treatment phases if they were present at a stable dose for at least 6 weeks prior to the start of initial ziprasidone treatment

- A score of 4 (moderate) or greater on any of the 7 items of the PANSS Positive Symptom Subscale

- Clinical judgment by the investigator that doses higher than 160 mg/day are warranted due to suboptimal clinical outcome despite adequate treatment at that dose

- Participant is judged capable of understanding all relevant risks and potential benefits of the study and has signed informed consent

- Comorbid axis 1 conditions (including anxiety disorders, eating disorders, impulse control disorders) are permitted if they have been stable and have not been a primary focus of treatment over the previous 6 months

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Past or current intolerance of ziprasidone side effects


- Presence of significant cardiac disease, including uncompensated congestive heart
failure, myocardial infarction within the past 6 months or known history of congenital
long QT interval syndrome


- Corrected QT interval (QTc) greater than or equal to 500 milliseconds (msec)


- Serum potassium and magnesium concentrations outside of normal limits.


- Currently taking any medications which may affect cardiac conduction


- Presence of any unstable or untreated medical disorder


- Any history of seizures or seizure disorder other than febrile seizures of childhood


- History of positive hepatitis B surface antigen


- Human immunodeficiency virus (HIV) positive or has diagnosis of acquired immune
deficiency syndrome (AIDS)


- Any abnormal laboratory test that is judged to be clinically significant by the
investigator


- History of neuroleptic malignant syndrome (NMS), hypersensitivity or allergic response
to antipsychotic therapy, including ziprasidone


- History of clozapine treatment for refractory psychotic symptoms


- Alcohol or substance dependence within the past 12 months or abuse within the past 3
months. Any subject with positive urine toxicology or alcohol use that is considered
abnormal at baseline.


- Clinically significant suicidal or homicidal behavior or attempts within past 6 months


- Any subject judged by the investigator to present a danger to self or others.


- Women of childbearing potential who are not using adequate contraception (oral
contraceptives, barrier methods or who are clearly abstinent)


- Pregnancy or breast-feeding


- Any subject who is judged by the investigator to be unable or unlikely to comply with
all study requirements, including adherence with prescribed medication regimen

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Advanced Information
Descriptive Information
Brief Title  ICMJE High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms
Official Title  ICMJE High-Dose Oral Ziprasidone Versus Conventional Dosing in Schizophrenia Patients With Residual Symptoms
Brief Summary

The primary aims of this study are to assess tolerability of ziprasidone dose escalation to 320 milligrams per day (mg/d) compared to continued standard treatment (placebo) as measured by the Side Effect Checklist, Simpson Angus Scale for Extrapyramidal Symptoms (SAS), Barnes Akathisia Scale (BAS), serum prolactin concentrations, vital signs, electrocardiogram (EKG) and completion rates and to assess whether ziprasidone dose escalation improves overall psychopathology compared to continued standard treatment as measured by the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score and response rates as defined by a 20% or greater reduction in PANSS total score.

The secondary aims of this study are to assess whether ziprasidone dose escalation improves psychotic symptoms compared to continued standard treatment as measured by the Positive Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves negative symptoms compared to standard treatment as measured by the Negative Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves depressive symptoms compared to continued standard treatment as measured by the Calgary Depression Rating Scale (CDRS), and to assess whether ziprasidone dose escalation improves overall functioning with the Clinical Global Impression - Severity (CGI-S), Clinical Global Impression - Improvement (CGI-I), Global Assessment of Functioning (GAF) and the Schizophrenia Cognition Rating Scale (SCoRS).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Ziprasidone 80-160 mg/d
    Participants will be instructed to take one study capsule of ziprasidone orally twice daily (80 mg/d). After the first week, the study drug will be increased to two capsules twice daily (160 mg/d).
    Other Name: Geodon
  • Drug: Placebo
    Participants will be instructed to take one study capsule of matching placebo orally twice daily. After the first week, the matching placebo will be increased to two capsules twice daily.
  • Drug: Ziprasidone 160 mg/d
    Participants will be taking open-label ziprasidone 80 mg orally twice daily for a total dose of 160 mg/d from at least 3 weeks before randomization to end of study 8 weeks after randomization.
    Other Name: Geodon
Study Arms  ICMJE
  • Experimental: High-Dose Ziprasidone
    Participants with schizophrenia or schizoaffective disorder who remain symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks will be instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug will be increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
    Interventions:
    • Drug: Ziprasidone 80-160 mg/d
    • Drug: Ziprasidone 160 mg/d
  • Placebo Comparator: Placebo, Standard Treatment Ziprasidone
    Participants with schizophrenia or schizoaffective disorder who remain symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks will be instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo will be increased to two capsules twice daily and their regular open-label ziprasidone will remain the same (160 mg/d) for 7 weeks.
    Interventions:
    • Drug: Placebo
    • Drug: Ziprasidone 160 mg/d
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2017)
131
Original Enrollment  ICMJE
 (submitted: November 22, 2006)
80
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Schizophrenia or Schizoaffective disorder, any subtype
  • Age 18-65 years
  • Treated with ziprasidone at a dose of 160 mg/d for at least 3 weeks with adequate compliance
  • Concomitant standing or other medications as needed (except other antipsychotics and those noted as contraindicated in the ziprasidone package insert) are permitted during all treatment phases if they were present at a stable dose for at least 6 weeks prior to the start of initial ziprasidone treatment
  • A score of 4 (moderate) or greater on any of the 7 items of the PANSS Positive Symptom Subscale
  • Clinical judgment by the investigator that doses higher than 160 mg/day are warranted due to suboptimal clinical outcome despite adequate treatment at that dose
  • Participant is judged capable of understanding all relevant risks and potential benefits of the study and has signed informed consent
  • Comorbid axis 1 conditions (including anxiety disorders, eating disorders, impulse control disorders) are permitted if they have been stable and have not been a primary focus of treatment over the previous 6 months

Exclusion Criteria:

  • Past or current intolerance of ziprasidone side effects
  • Presence of significant cardiac disease, including uncompensated congestive heart failure, myocardial infarction within the past 6 months or known history of congenital long QT interval syndrome
  • Corrected QT interval (QTc) greater than or equal to 500 milliseconds (msec)
  • Serum potassium and magnesium concentrations outside of normal limits.
  • Currently taking any medications which may affect cardiac conduction
  • Presence of any unstable or untreated medical disorder
  • Any history of seizures or seizure disorder other than febrile seizures of childhood
  • History of positive hepatitis B surface antigen
  • Human immunodeficiency virus (HIV) positive or has diagnosis of acquired immune deficiency syndrome (AIDS)
  • Any abnormal laboratory test that is judged to be clinically significant by the investigator
  • History of neuroleptic malignant syndrome (NMS), hypersensitivity or allergic response to antipsychotic therapy, including ziprasidone
  • History of clozapine treatment for refractory psychotic symptoms
  • Alcohol or substance dependence within the past 12 months or abuse within the past 3 months. Any subject with positive urine toxicology or alcohol use that is considered abnormal at baseline.
  • Clinically significant suicidal or homicidal behavior or attempts within past 6 months
  • Any subject judged by the investigator to present a danger to self or others.
  • Women of childbearing potential who are not using adequate contraception (oral contraceptives, barrier methods or who are clearly abstinent)
  • Pregnancy or breast-feeding
  • Any subject who is judged by the investigator to be unable or unlikely to comply with all study requirements, including adherence with prescribed medication regimen
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00403546
Other Study ID Numbers  ICMJE 2005-P-001372
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Donald C. Goff, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Donald C. Goff, MD
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Donald Goff, M.D.Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP