Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    NCT00143351
Previous Study | Return to List | Next Study

Mozart Relapse Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00143351
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 1, 2007
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 31, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date January 1, 2007
Study Start Date  ICMJE June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
long-term efficacy of oral Ziprasidone in the maintenance treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
To assess the efficacy of ziprasidone in the relapse prevention of schizophrenia To collect long-term data on safety and tolerability of oral Ziprasidone
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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