Mozart Relapse Study

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143351
First received: August 31, 2005
Last updated: December 28, 2006
Last verified: December 2006
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Ziprasidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • long-term efficacy of oral Ziprasidone in the maintenance treatment

Secondary Outcome Measures:
  • To assess the efficacy of ziprasidone in the relapse prevention of schizophrenia To collect long-term data on safety and tolerability of oral Ziprasidone

Estimated Enrollment: 75
Study Start Date: June 2003
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143351

Locations
Italy
Pfizer Investigational Site
Vicenza, Bassano Del Grappa, Italy, 36061
Pfizer Investigational Site
Citta' Di Castello, Perugia, Italy, 06012
Pfizer Investigational Site
Bari, Italy, 70100
Pfizer Investigational Site
Brescia, Italy, 25100
Pfizer Investigational Site
Catania, Italy, 95123
Pfizer Investigational Site
Guardiagrele (ch), Italy, 66016
Pfizer Investigational Site
Messina, Italy, 98100
Pfizer Investigational Site
Parma, Italy, 43100
Pfizer Investigational Site
Roma, Italy, 00135
Pfizer Investigational Site
Roma, Italy, 00137
Pfizer Investigational Site
Roma, Italy, 00100
Pfizer Investigational Site
Sassari, Italy, 07100
Pfizer Investigational Site
Terni, Italy
Pfizer Investigational Site
Torino, Italy, 10126
Pfizer Investigational Site
Trieste, Italy, 34126
Pfizer Investigational Site
Verona, Italy, 37100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00143351     History of Changes
Other Study ID Numbers: A1281088
Study First Received: August 31, 2005
Last Updated: December 28, 2006
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 23, 2014