Lurasidone Extended Use Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01485640
• Date of registration: 01/12/2011
• Prospective Registration: No
• Primary sponsor: Sunovion
• Public title: Lurasidone Extended Use Study
• Scientific title: A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study
• Date of first enrolment: June 2011
• Target sample size: 162
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01485640
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, Colombia, Czech Republic, France, India, Lithuania, Romania, Russian Federation, Serbia, Slovakia, South Africa, Ukraine

Contacts

• Name: Medical Director, MD
• Affiliation: Sunovion

Key inclusion & exclusion criteria

Inclusion Criteria:

- The subject or legal guardian provides written informed consent. For eligible subjects
under age 18, verbal assent is also required.

- The subject has completed the extension phase of a prior lurasidone clinical study.
Eligible subjects may enroll into this continuation study directly (or within 10 days)
after completing the extension phase of a prior lurasidone clinical study. Subjects
that have completed an extension study prior to the initiation of this protocol at the
study site, may participate in this study up to 3 months after completion of the
extension phase of the prior lurasidone study.

- The subject is judged by the Investigator to be suitable for participation in a
clinical study involving open-label lurasidone treatment and is able to comply with
the protocol.

- The subject, in the Investigator's judgment, may benefit from continued treatment with
lurasidone

Exclusion Criteria:

- The subject is considered by the Investigator, to be at imminent risk for homicidal or
suicidal behavior.

- The subject resides in a country where lurasidone has been approved for any
indication.

- The subject is currently enrolled in any other investigational study.

- The subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide
Severity Rating Scale (C-SSRS).



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bipolar Disorder

Schizophrenia

Intervention(s)

Drug: Lurasidone

Primary Outcome(s)

Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs [Time Frame: 18 months]

Secondary Outcome(s)

Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S [Time Frame: 18 months]

Secondary ID(s)

2011-000682-12

D1050298

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/03/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01485640