Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Ziprasidone
Intervention description: 20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 344.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Open-label extension Ziprasidone study in Schizophrenia

Summary:

      To provide treatment to eligible subjects who have successfully completed one of the
      following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or
      A1281088 (NCT00143351).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have successfully completed a ziprasidone clinical study

          -  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; an adequate
             method of contraception (intrauterine device, implanted contraceptive, oral
             contraceptive or condom) must be initiated or continued

        Exclusion Criteria:

        Psychiatric:

          -  Subjects at immediate risk of committing harm to self or others

          -  Subjects requiring concurrent treatment with non-study antipsychotic agents

          -  Subjects requiring treatment with antidepressants or mood stabilizers

          -  General:

          -  Subjects with a history of clinically significant and/or currently relevant
             hematological, 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 (excluding melanoma). 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

          -  Acute or chronic heart disease

          -  Clinically significant ECG abnormalities

          -  Subjects with QTc >= 500 msec (subjects with QTc >= 450 msec and < 500 msec should be
             discussed with the cardiologist who is responsible for all of the centers involved)

          -  Concomitant treatment with medications that prolong QTc interval (please review
             prescribing information of other treatments)

          -  Subjects with serum K+ or Mg++ outside the normal range

          -  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

          -  Known serological evidence of HIV, or acute or chronic hepatitis (with transaminase
             levels higher than three times upper limit)

          -  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

          -  Known hypersensitivity to ziprasidone or lactose