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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01566162
Other study ID # D1050307
Secondary ID 2011-004790-90
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2012
Est. completion date November 2013

Study information

Verified date April 2019
Source Sunovion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.


Description:

This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia who have participated in Study D1050238, a double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia. Subjects who have completed the 28-week double-blind phase or who have experienced a protocol-defined relapse event during the double-blind phase of study D1050238 will have the option to participate in this study. In addition, if/when the study is discontinued by the sponsor, all subjects participating in the open-label phase and the double-blind phase of study D1050238 will have the option to participate in this extension study


Recruitment information / eligibility

Status Completed
Enrollment 191
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject has agreed to participate by providing written informed consent.

- Subject will be eligible to participate if one of the following criteria is met:

- Subject has completed the 28-week double-blind phase of study D1050238

- Subject has experienced a protocol-defined relapse event during the double- blind phase in study D1050238

- Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor.

- Subject has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238.

- Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

- Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

- Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at the extension baseline visit (Study Visit Number 42 in study D1050238). Subjects who answer "yes" to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment.

- Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at the extension baseline visit (Study Visit Number 42 in study D1050238). In the event a subject tests positive for cannabinoids, the Investigator will evaluate the subject's ability to abstain from cannabis during the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lurasidone
Lurasidone 40-80 mg taken orally taken once daily

Locations

Country Name City State
France Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP) Dole
France Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS) Toulon
Italy Dipartimento Salute Mentale ASL 1 Massa
Italy A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4 Pisa
Russian Federation Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital' Lipetsk
Russian Federation Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix' Rostov-on-Don
Russian Federation St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6" St. Peterburg
Russian Federation St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7") St. Petersburg
Russian Federation St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1 St. Petersburg
Russian Federation St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor) St. Petersburg
Serbia Military Medical Academy, Clnic for Psychiatry Belgrade
Serbia Institute of Mental Health Dusica
Serbia Clinical Centre Kragujevac, Clinic for psychiatry Kragujevac
Serbia Clinical Centre Nis, Clinic for mental health protection Nis
Serbia Specialized hospital for psychiatric diseases "Sveti Vracevi" Novi Knezevac
Serbia Clinical Centre Vojvodine, Clinic for Psychiatry Novi Sad
Slovakia Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie Bojnice
Slovakia Psychiatricka ambulancia Mentum s.r.o. Bratislava
Slovakia Psychiatricka nemocnica Michalovce n.o. Michalovce
Slovakia PsychoLine s.r.o. Psychiatricka ambulancia Rimavska Sobota
Slovakia Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie Roznava
Slovakia "Centrum zdravia R.B.K., spol. s.r.o. Svidnik
South Africa Research Unit, Department of Psychiatry Free State Psychiatric Complex Bloemfontein
South Africa Denmar Hospital Consulting Rooms Pretoria
South Africa Cape Trial Centre Tygervalley Western Cape
United States Atlanta Center for Medical Research Atlanta Georgia
United States Comprehensive NeuroScience Inc. Atlanta Georgia
United States Community Clinical Research, Inc. Austin Texas
United States FutureSearch Clinical Trials LP Austin Texas
United States Florida Clinical Research Center, LLC Bradenton Florida
United States Erie County Medical Center, Corp Buffalo New York
United States Neurobehavioral Research Inc. Cedarhurst New York
United States Comprehensive Clinical Development Inc. Cerritos California
United States FutureSearch Clinical Trials, LP Dallas Texas
United States Pillar Clinical Research, LLC Dallas Texas
United States Diligent Clinical Trials Downey California
United States Synergy Clinical Research Center Escondido California
United States Comprehensive Clinical Development, Inc Fresh Meadows New York
United States CNS Network Garden Grove California
United States Accurate Clinical Trials Kissimmee Florida
United States Lake Charles Clinical Trials, LLC Lake Charles Louisiana
United States Robert Lynn Horne, MD Las Vegas Nevada
United States Lincoln Research Lincoln Rhode Island
United States K and S Professional Research Services Little Rock Arkansas
United States Woodland International Research Inc. Little Rock Arkansas
United States AXIS Clinical Trials Los Angeles California
United States Galiz Research Miami Springs Florida
United States Synergy Clinical Research Center National City California
United States Psychiatric Care and Research Center O'Fallon Missouri
United States Excell Research, Inc. Oceanside California
United States Oklahoma Clinical Research Oklahoma City Oklahoma
United States Medical Research Group of Central Florida Orange City Florida
United States CRI Worldwide LLC at Kirkbride Philadelphia Pennsylvania
United States CNRI-Los Angeles. LLC Pico Rivera California
United States Finger Lakes Clinical Research Rochester New York
United States Center for Behavioral Health, LLC Rockville Maryland
United States Psych Care Consultants Research Saint Louis Missouri
United States Department of Psychiatry, University of Utah Health Sciences Center Salt Lake City Utah
United States California Neuropsychopharmacolgoy Clinical Research Insitute San Diego California
United States Neuropsychiatric Research Center of Orange County Santa Ana California
United States Lousiana Clinical Research, LLC Shreveport Louisiana
United States Collaborative Neuroscience Network Torrance California
United States CRI Worldwide LLC Willingboro New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  France,  Italy,  Russian Federation,  Serbia,  Slovakia,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs) Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs) 12 weeks
Primary Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. Baseline to week 12 LOCF endpoint
Primary Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score. The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. Baseline to week 12 LOCF endpoint
Secondary Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity. Baseline to week 12 LOCF endpoint
Secondary Short Form-12 Health Survey (SF-12) The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Baseline to week 12 LOCF endpoint
Secondary Modified Specific Levels of Functioning (SLOF) Total Score. The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition. 12 weeks
Secondary Brief Adherence Rating Scale (BARS) The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month. 12 weeks
Secondary Smoking Questionnaire Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF). 12 weeks
Secondary Intent to Attend Assessment The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = "Not at all" and 9 = "Extremely". The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: "How likely is it that you will complete the study?" 12 weeks
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