Lurasidone Extended Use Study

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01485640
• Collaborator: (none)
• Enrollment: 162
• Locations: 46
• Arm: 1
• Duration (Months): 32.1
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Bipolar Disorder	Drug: Lurasidone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 162 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lurasidone Lurasidone flexibly dosed	Drug: Lurasidone; Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs [18 months]

   Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.

Secondary Outcome Measures

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

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Okanagan Clinical Trials	Kelowna	British Columbia	Canada	V1Y 1Z9
2	Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations	Barranquilla		Colombia
3	E.S.E. Hospital Mental de Antioquia	Bello		Colombia
4	CISNE - UIC Campo Abierto	Bogota		Colombia
5	Psychiatricka ambulance	Brno-mesto		Czech Republic	602 00
6	Vojenska nemocnice Olomouc	Olomouc		Czech Republic	711 11
7	Clintrial, s.r.o.	Praha		Czech Republic	10 100 00
8	Psychiatry Trial s.r.o.	Praha		Czech Republic	158 00
9	Medical Services Prague s.r.o.	Praha		Czech Republic	6 160 00
10	Zans Ritter, Marcel	Orvault		France	44700
11	Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)	Toulun		France	83000
12	Brain Mind Behavior Neuroscience Research Institute	Vishakhapatnam	Andh Prad	India	530002
13	Vijayawada Institute of Mental Health and Neurosciences	Vijayawada	Andhra Pradesh	India	520002
14	Samvedna Hospitals	Ahmedabad	Gujarat	India	380006
15	Seth K M School of P G Medicine & Research	Ahmedabad	Gujarat	India	380006
16	Mental Health Treatment Rehabililitation Foundation Dept. of Psychiatry	Ahmedabad	Gujarat	India	380013
17	Hatkesh Healthcare Foundation	Junagadh	Gujarat	India	362001
18	Brij Psychiatry Hospital & Muskaan Research Centre	Vadodara	Gujarat	India	390001
19	Shanti Nursing Home	Aurangabad	Maharashtra	India	431005
20	Dr. Tambi's Neuropsychiatry Center	Jaipur	Rajaasthan	India	302017
21	R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry	Jaipur	Rajasthan	India	302021
22	Mahendru Psychiatric Centre	Kanpur		India	208005
23	Neuromeda JSC	Kaunas		Lithuania	50185
24	JSC Neuromeda	Kaunas		Lithuania	LT-50185
25	Seskines Outpatient Clinic, Public Institution	Vilnius		Lithuania	07156
26	Spitalul Clinic Judetean de Urgenta Cluj	Cluj-Napoca		Romania	400012
27	Spitalul Clinic de Neuropsihiatrie Craiova	Craiova		Romania	200620
28	Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'	Lipetsk		Russian Federation	398007
29	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	19005
30	St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)	St. Petersburg		Russian Federation	191119
31	St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"	St. Petersburg		Russian Federation	191167
32	Institute of Mental Health	Belgrade		Serbia	11000
33	Clinical Centre Nis, Clinic for mental health protection	Nis		Serbia	18000
34	Psychiatricka ambulancia Mentum s.r.o.	Bratislava		Slovakia	82007
35	PsychoLine s.r.o. Psychiatricka ambulancia	Rimavska Sobota		Slovakia	97901
36	Centrum zdravia R.B.K. s.r.o. Psychiatricka ambulancia	Svidnik		Slovakia	08901
37	Pro mente sana s.r.o. Psychiaricka ambulancia	Trencin		Slovakia	91101
38	Dey Clinic	Pretoria	Gauteng	South Africa	181
39	Cape Trial Centre	Tygervalley	Western Cape	South Africa	7530
40	Denmar Hospital Consulting Rooms	Pretoria		South Africa	0081
41	Kherson Regional Psychiatric Hospital	Kherson	Vil Stepanivka	Ukraine	73488
42	Dnipropetrovsk Regional Clinical Hospital named Mechnikov	Dnipropetrovsk		Ukraine	49005
43	Regional Clinical Psychiatric Hospital, Dept #11	Donetsk		Ukraine	83037
44	Institute of Neurology, Psychiatry and Narcology, NAMS of Ukraine	Khardov		Ukraine	61068
45	Crimean republican Clinical Psychiatric Hospital	Simferopol		Ukraine
46	Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21	Vinnitsia		Ukraine	21018

Sponsors and Collaborators

• Sunovion

Investigators

• Study Director: Medical Director, MD, Sunovion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT01485640
• Other Study ID Numbers: D1050298; 2011-000682-12
• First Posted: Dec 5, 2011
• Last Update Posted: Nov 4, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by Sunovion: Schizophrenia; bipolar disorder; Lurasidone; Latuda
• Additional relevant MeSH terms: Schizophrenia; Bipolar Disorder; Lurasidone Hydrochloride

Study Results

Participant Flow

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Period Title: Overall Study
STARTED	162
COMPLETED	40
NOT COMPLETED	122

Baseline Characteristics

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Overall Participants	162
Age (Count of Participants)
<=18 years	1 0.6%
Between 18 and 65 years	159 98.1%
>=65 years	2 1.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.3 (12.08)
Sex: Female, Male (Count of Participants)
Female	77 47.5%
Male	85 52.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	32 19.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 3.1%
White	105 64.8%
More than one race	0 0%
Unknown or Not Reported	20 12.3%
Region of Enrollment (participants) [Number]
Serbia	6 3.7%
France	6 3.7%
Czech Republic	25 15.4%
Slovakia	17 10.5%
Canada	3 1.9%
Ukraine	11 6.8%
Romania	2 1.2%
Lithuania	8 4.9%
Russian Federation	20 12.3%
South Africa	26 16%
Colombia	6 3.7%
India	32 19.8%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs
Description	Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

Safety Population - subjects who took at least one dose of study medication

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Measure Participants	162
Subject with at least on treatment emergent AE	63 38.9%
Subject with at least one treatment emergent SAE	7 4.3%
Subjects discontinued due to TEAE	10 6.2%

2. Secondary Outcome

Title	Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S
Description	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.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

Only 153 subjects who had baseline and at least one post-baseline assessments.

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Measure Participants	153
Mean (Standard Deviation) [units on a scale]	-0.18 (0.877)

Adverse Events

Time Frame	18 Months
Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone flexibly dosed Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
All Cause Mortality
	Lurasidone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lurasidone
	Affected / at Risk (%)	# Events
Total	7/162 (4.3%)
Infections and infestations
Pilonidal cyst	1/162 (0.6%)	1
Injury, poisoning and procedural complications
Foot fracture	1/162 (0.6%)	1
Psychiatric disorders
Depression	1/162 (0.6%)	1
Depression suicidal	1/162 (0.6%)	1
Mania	2/162 (1.2%)	2
Schizophrenia, paranoid type	1/162 (0.6%)	1
Other (Not Including Serious) Adverse Events
	Lurasidone
	Affected / at Risk (%)	# Events
Total	40/162 (24.7%)
Gastrointestinal disorders
Diarrhoea	6/162 (3.7%)	8
Vomiting	5/162 (3.1%)	11
Nausea	4/162 (2.5%)	4
Infections and infestations
Influenza	6/162 (3.7%)	6
Nasopharyngitis	6/162 (3.7%)	9
Viral upper respiratory tract infection	4/162 (2.5%)	4
Investigations
Hepatic enzyme increase	4/162 (2.5%)	4
Nervous system disorders
Headache	9/162 (5.6%)	12
Psychiatric disorders
Anxiety	5/162 (3.1%)	11
Insomnia	5/162 (3.1%)	6
Depression	4/162 (2.5%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS agreement between Principal Investigator and Sponsor that restricts PI's rights to discuss or publish trial results after trial is completed. In addition to the <60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication provided, if a multicenter publication is not forthcoming within 24 months post completion of study at all sites, PI shall be free to publish.