ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
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Descriptive Information | ||||
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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 | 75 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | September 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |