Mozart Relapse Study

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00143351

Enrollment

Registered

2005-09-02

Start date

2003-06-30

Completion date

2005-09-30

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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

Interventions

DRUGZiprasidone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
long-term efficacy of oral Ziprasidone in the maintenance treatment	—

Secondary

Measure	Time frame
To assess the efficacy of ziprasidone in the relapse prevention of schizophrenia To collect long-term data on safety and tolerability of oral Ziprasidone	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026