High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms
NCT00403546
ABOUT THIS STUDY
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- 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
- 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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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 131 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |