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Mozart Relapse Study

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NCT00143351

Last updated on January 19, 2020
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Vicenza, Bassano Del Grappa, 36061 Italy
See other locations
Contact
1-800-718-1021
[email protected]
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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 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects who have completed MOZART study and who are responders to Ziprasidone:

- Responders: patients with a 20% or more reduction in the PANSS total score at the
endpoint of the Mozart Study (recorded at V18 in the Mozart) as compared with the
baseline value

- Patients not hospitalised in an acute psychiatric service

- Written, informed consent to participation.

- Female patients of at risk of pregnancy must avoid to remain pregnant; if already
used, an adequate method of contraception can be continued

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

- Psychiatric:

- Subjects with a score of greater than or equal to 5 and an increase of at least 2
points (with respect to baseline value of MOZART study) at one of the following PANSS
items: P7 (hostility), G8 (uncooperativeness) or G14 (poor control impulse)

- Subjects with a score equal to 3 and an increase of at least 1 point (with respect to
baseline value of MOZART study) at item 8 (suicide) of CDSS

- General:

- Patients who, during MOZART study, have developed one of the following diseases will
be excluded: (or patients who do not satisfy anymore one of the following general
exclusion criteria of MOZART study)

- Subjects with a history of clinically significant and/or currently relevant
haematological, renal (including single kidney), hepatic, gastrointestinal, endocrine
(except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding
chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease),
dermatological, oncological, or neurological disease, excluding tardive dyskinesia but
including all forms of epilepsy (febrile convulsions in childhood acceptable). The
only subjects with known prior malignant disease who are eligible are those with cured
prior skin cancer. Controlled Type II diabetes (glucose and baseline with dietary or oral hypoglycemic treatment) will not be considered a
significant medical illness and would not exclude a subject from the study

- Patients with a non stabilized somatic disease - Acute or chronic heart disease

- Clinically significant ECG abnormalities

- Subjects with QTc greater than or equal to 500 msec (subjects with QTc greater than or
equal to 450 msec and Concomitant treatment with medications that prolong QTc interval (please review
prescribing information of other treatments)

- Subjects with serum K+ outside the normal range

- History of seizure (should be discussed with the Sponsor)

- Subject with any confirmed laboratory values that deviate from the upper or lower
limits of normal prior to study entry, except for clinically insignificant deviations
as determined by investigator

- Pregnant or lactating women

- Subjects who intend to donate blood or blood products during the 4 weeks prior to the
study, during the study or in the 30 days after the study ends

- Subjects unable or unlikely to follow the study protocol

- Subjects with a history of neuroleptic malignant syndrome developing from the
administration of antipsychotic compounds

- Diagnosis of substance dependence using DSM-IV criteria (305.xx)

- Positive urine drug screen at screening for amphetamines, cocaine or opioids

NCT00143351
Pfizer
Completed
Mozart Relapse Study

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Descriptive Information
Brief Title  ICMJE Mozart Relapse Study
Official Title  ICMJE Open Extension Study Evaluating the Long-Term Efficacy, Safety, and Tolerability of Oral Ziprasidone in the Treatment of Resistant/Intolerant Schizophrenic Patients Who Have Acutely Responded to Ziprasidone in the Mozart Study
Brief Summary To assess the long-term efficacy of oral Ziprasidone in the maintenance treatment of resistant schizophrenic subjects who have benefited from participation in the phase III ziprasidone study A1281039 (MOZART study), to assess the efficacy of ziprasidone in the relapse prevention of schizophrenia, to collect long-term data on safety and tolerability of oral Ziprasidone
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: Ziprasidone
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: August 31, 2005) 		75
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who have completed MOZART study and who are responders to Ziprasidone:
  • Responders: patients with a 20% or more reduction in the PANSS total score at the endpoint of the Mozart Study (recorded at V18 in the Mozart) as compared with the baseline value
  • Patients not hospitalised in an acute psychiatric service
  • Written, informed consent to participation.
  • Female patients of at risk of pregnancy must avoid to remain pregnant; if already used, an adequate method of contraception can be continued

Exclusion Criteria:

  • Psychiatric:
  • Subjects with a score of greater than or equal to 5 and an increase of at least 2 points (with respect to baseline value of MOZART study) at one of the following PANSS items: P7 (hostility), G8 (uncooperativeness) or G14 (poor control impulse)
  • Subjects with a score equal to 3 and an increase of at least 1 point (with respect to baseline value of MOZART study) at item 8 (suicide) of CDSS
  • General:
  • Patients who, during MOZART study, have developed one of the following diseases will be excluded: (or patients who do not satisfy anymore one of the following general exclusion criteria of MOZART study)
  • Subjects with a history of clinically significant and/or currently relevant haematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only subjects with known prior malignant disease who are eligible are those with cured prior skin cancer. Controlled Type II diabetes (glucose < 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study
  • Patients with a non stabilized somatic disease - Acute or chronic heart disease
  • Clinically significant ECG abnormalities
  • Subjects with QTc greater than or equal to 500 msec (subjects with QTc greater than or equal to 450 msec and < 500 msec should be discussed with the cardiologist) - Concomitant treatment with medications that prolong QTc interval (please review prescribing information of other treatments)
  • Subjects with serum K+ outside the normal range
  • History of seizure (should be discussed with the Sponsor)
  • Subject with any confirmed laboratory values that deviate from the upper or lower limits of normal prior to study entry, except for clinically insignificant deviations as determined by investigator
  • Pregnant or lactating women
  • Subjects who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends
  • Subjects unable or unlikely to follow the study protocol
  • Subjects with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds
  • Diagnosis of substance dependence using DSM-IV criteria (305.xx)
  • Positive urine drug screen at screening for amphetamines, cocaine or opioids
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143351
Other Study ID Numbers  ICMJE A1281088
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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