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SchizophreniaPhase 3NCT00143351

Mozart Relapse Study

A Phase 3 study testing Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 16 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
What is being tested?
Ziprasidone
How many people
75 participants
Where
16 sitesItaly
Study dates
Jun 2003to Sep 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Italy16 sites

  • Pfizer Investigational Site

    Bari, 70100

  • Pfizer Investigational Site

    Brescia, 25100

  • Pfizer Investigational Site

    Catania, 95123

  • Pfizer Investigational Site

    Città di Castello, Perugia, 06012

  • Pfizer Investigational Site

    Guardiagrele (CH), 66016

  • Pfizer Investigational Site

    Messina, 98100

  • Pfizer Investigational Site

    Parma, 43100

  • Pfizer Investigational Site

    Roma, 00100

  • Pfizer Investigational Site

    Roma, 00135

  • Pfizer Investigational Site

    Roma, 00137

  • Pfizer Investigational Site

    Sassari, 07100

  • Pfizer Investigational Site

    Terni

  • Pfizer Investigational Site

    Torino, 10126

  • Pfizer Investigational Site

    Trieste, 34126

  • Pfizer Investigational Site

    Verona, 37100

  • Pfizer Investigational Site

    Vicenza, Bassano DEL Grappa, 36061

Other trials in Italy

About this study

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

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

Conditions
Schizophrenia
Being tested
Ziprasidone
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZiprasidoneDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. long-term efficacy of oral Ziprasidone in the maintenance treatment

Secondary outcomes (1)

  1. To assess the efficacy of ziprasidone in the relapse prevention of schizophrenia To collect long-term data on safety and tolerability of oral Ziprasidone

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2005 (estimated)
  2. Study startJun 2003
  3. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00143351
Sponsor's protocol ID
A1281088
Status last verified
Feb 2021
First submitted
31 Aug 2005
Last updated
21 Feb 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 16 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

long-term efficacy of oral Ziprasidone in the maintenance treatment. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00143351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.

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