PERSISTExt: This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01575561
• Collaborator: (none)
• Enrollment: 377
• Locations: 71
• Arm: 1
• Duration (Months): 37
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

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

Detailed Description

To evaluate the longer term safety of lurasidone (20, 40, 60 or 80 mg/day) in subjects with bipolar I disorder.

Subjects will be initially treated with open-label lurasidone 40 mg/day (Day 1).

Dose adjustment of study drug (20, 40, 60 or 80 mg /day) should occur at the regularly scheduled visits and in increments/decrements of 1 dose level.

Study Design

• Study Type: Interventional
• Actual Enrollment: 377 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lurasidone Lurasidone 20, 40, 60,80 mg flexible dose	Drug: Lurasidone; Lurasidone 20-80 mg taken orally once daily

Outcome Measures

Primary Outcome Measures

1. Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events [12 weeks]

   Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation

Secondary Outcome Measures

1. Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score [baseline, 12 weeks (LOCF)]

   The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.

2. Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score [baseline, 12 weeks (LOCF)]

   The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. 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-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.

3. Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS) [Baseline, 12 weeks (LOCF)]

   Movement disorders as assessed by Young Mania Rating Scale (YMRS) The YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of mania.

4. Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS) [baseline ,Week 12 (LOCF)]

   Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) -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 of depression.

5. Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) [baseline, week 12 (LOCF)]

   Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) -The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar 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.

6. Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score [baseline, week 12 (LOCF)]

   The CGI-BP-S mania score is a single value, clinician-rated assessment of mania 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

7. Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale [baseline, week 12 (LOCF)]

   The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and range from 1=normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with greater illness severity.

8. Change From Baseline to Week 12 (LOCF) in the SDS Total Score [baseline, week 12 (LOCF)]

   The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• Subject has completed the 28 week Double-blind Phase of Study D1050296 and all required assessments on the final study visit (Week 28, Visit 28); OR

• Subject has experienced a protocol-defined recurrence of any mood event during the Double blind Phase of Study D1050296 and has completed all required assessments on the final study visit; OR

• Subject had at least entered the Open-label Phase of Study D1050296 when the Sponsor stopped the study and has completed all required assessments on the final study visit.

• 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 Columbia Suicide Severity Rating Scale (C-SSRS) at the extension baseline visit (final study visit in Study D1050296).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harmonex Neuroscience Research	Dothan	Alabama	United States	36303
2	Behavioral Research Specialists, LLC	Glendale	California	United States	91206
3	AXIS Clinical Trials	Los Angeles	California	United States	90036
4	Excell Research, Inc	Oceanside	California	United States	92056
5	Stanford University School of Medicine Research Program VA Palo Alto Health Care System	Palo Alto	California	United States	93404
6	SF-Care, Inc.	San Francisco	California	United States	94117
7	Neuropsychiatric Research Center of Orange County	Santa Ana	California	United States	92701
8	Stanford University School of Medicine	Stanford	California	United States	93405
9	Florida Clinical Research LLC	Bradenton	Florida	United States	34201
10	Clinical Neuroscience Solutions Inc.	Jacksonville	Florida	United States	32216
11	Galiz Research	Miami Springs	Florida	United States	33166
12	Clinical Neuroscience Solutions	Orlando	Florida	United States	32806
13	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30308
14	Clinco	Terre Haute	Indiana	United States	47802
15	Activ Med Practices & Research	Haverhill	Massachusetts	United States	08130
16	Psych Care Consultants Research	St. Louis	Missouri	United States	63128
17	Finger Lakes Clinical Research	Rochester	New York	United States	14618
18	Charak Clincial Research Center	Garlield Heights	Ohio	United States	44125
19	Cutting Edge Research Group	Oklahoma City	Oklahoma	United States	73116
20	Suburban Research Associates	Media	Pennsylvania	United States	19063
21	Lincoln Research	Lincoln	Rhode Island	United States	02865
22	Carolina Clinical Trials	Charleston	South Carolina	United States	29407
23	Clinical Neuroscience Solutions Inc.	Memphis	Tennessee	United States	38119
24	Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center	Dallas	Texas	United States	75235
25	R/D Clinical Research, Inc.	Lake Jackson	Texas	United States	77566
26	Clinica Privada de Salud Mental Santa Teresa de Avila	Buenos Aires		Argentina	1900
27	Novain Neurociencias Group	Buenos Aires		Argentina	C1117ABH
28	Instituto Nacional de Psicopatología (INAPSI)	Buenos Aires		Argentina	C1405BOA
29	Fundacion para el estudio y tratamiento de las enfermedades mentales (FETEM)	Buenos Aires		Argentina	C1425AHQ
30	Instituto DAMIC SRL	Cordoba		Argentina	5003
31	Centro de Investigacion y Asistencia en Psiquiatria (CIAP)	Rosario		Argentina	2000
32	Center for Mental Health	Rousse		Bulgaria	7003
33	Multiprofiled Hospital for Active Treatment "Alexandrovska"	Sofia		Bulgaria	1431
34	Military Medical Academy	Sofia		Bulgaria	1606
35	Hospital El Pino	Santiago		Chile	8053095
36	Clinica Pedro Montt	Santiago		Chile	8330838
37	Saint Anne, s.r.o., Psychiatricke oddeleni	Brno - mesto		Czech Republic	602 00
38	Psychiatricka ambulance	Havirov		Czech Republic	73601
39	Psychiatricka lecebna U Honzicka	Pisek		Czech Republic	397 01
40	Psychiatricka ambulance	Prague		Czech Republic	149 00
41	Clintrial s.r.o.	Praha		Czech Republic	100 00
42	Psychiatricka ambulance	Praha		Czech Republic	106 00
43	Psychiatricka ambulance Prosek	Praha		Czech Republic	190 00
44	Telemens, s.r.o.	Prerov		Czech Republic	750 01
45	CHS La Chartreuse - Pôle 6	Dijon cedex		France	21033
46	Centre Hospitalier Spécialisé du Jura - Centre Médico Psychiatrique	Dole		France	39100
47	Centre Hospitalier Régional Universitaire	Nimes		France	30900
48	Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika	Budapest		Hungary	1125
49	Nyiro Gyula Korhaz, I. Pszichiatria	Budapest		Hungary	1135
50	Nyiro Gyula Korhaz, II. Pszichiatria	Budapest		Hungary	1135
51	Nyiro Gyula Korhaz	Budapest		Hungary	1135
52	Goryokai Medical Corporation	Sapporo-shi	Hokkaido	Japan	002-8029
53	Asakayama General Hospital	Sakai	Osaka	Japan
54	Yuge Hospital	Kumamoto		Japan	861-8002
55	Nishigahara Hospital	Tokyo		Japan	114-0024
56	Kawada Hospital	Toyama		Japan	933-0917
57	NZOZ Syntonia	Gdynia		Poland	81-361
58	NZOZ BioMed	Kielce		Poland	25-411
59	NZOZ Prywatna Klinika Psychiatryczna Inventiva	Tuszyn		Poland	95-080
60	State Healthcare and Forensic Psychiatric Expertise Institution	Izhevsk		Russian Federation	426054
61	Nizhny Novgorod Regional State Institution of Healthcare	Novgorod		Russian Federation	603155
62	St Petersburg State Government Healthcare Institution	St Petersburg		Russian Federation	190121
63	Saint Petersburg State Healthcare Institution "City psycho-neurology Dispanser #7"	St. Petersburg		Russian Federation	190005
64	St. Petersburg State Healthcare Institution "City Clinical Hospital #4"	St. Petersburg		Russian Federation	191119
65	Mental Health Research Institute of Siberian Branch of RAMS	Tomsk		Russian Federation	634014
66	Clinical Hospital Centre Dragisa Misovic	Belgrade		Serbia	11000
67	Clinical Centre Kragujevac, Psychiatric Hospital	Kragujevac		Serbia	34000
68	Clinic for Mental Health Protection, Clinical Centre Nis	Nis		Serbia	18000
69	Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"	Novi Knezevac		Serbia	23330
70	Psychiatricke oddelenie, Vseobecna nemocnica Rimavska Sobota NaP n.o.	Rimavska Sobota		Slovakia	97912
71	Psychiatricka ambulancia	Zlate Moravce		Slovakia	95301

Sponsors and Collaborators

• Sunovion

Investigators

• Study Director: Lurasidone Medical Director, MD, Sunovion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT01575561
• Other Study ID Numbers: D1050308; 2011-004789-14
• First Posted: Apr 11, 2012
• Last Update Posted: Aug 22, 2016
• Last Verified: Jul 1, 2016

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

Study Results

Participant Flow

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone 20, 40, 60,80 mg flexible dose Lurasidone: Lurasidone 20-80 mg taken orally once daily
Period Title: Overall Study
STARTED	377
COMPLETED	338
NOT COMPLETED	39

Baseline Characteristics

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone 20, 40, 60,80 mg flexible dose Lurasidone: Lurasidone 20-80 mg taken orally once daily
Overall Participants	377
Age (Count of Participants)
<=18 years	1 0.3%
Between 18 and 65 years	359 95.2%
>=65 years	17 4.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.5 (12.27)
Sex: Female, Male (Count of Participants)
Female	206 54.6%
Male	171 45.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	62 16.4%
Not Hispanic or Latino	315 83.6%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.3%
Asian	15 4%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	28 7.4%
White	327 86.7%
More than one race	0 0%
Unknown or Not Reported	6 1.6%
Region of Enrollment (participants) [Number]
Czech Republic	40 10.6%
Russian Federation	42 11.1%
Argentina	30 8%
Hungary	21 5.6%
United States	95 25.2%
Japan	13 3.4%
Poland	37 9.8%
Slovakia	5 1.3%
Bulgaria	34 9%
France	8 2.1%
Chile	17 4.5%
Serbia	35 9.3%

Outcome Measures

1. Primary Outcome

Title	Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events
Description	Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone 20, 40, 60,80 mg flexible dose Lurasidone: Lurasidone 20-80 mg taken orally once daily
Measure Participants	377
at Least 1 TEAE potentially related to study drug	155 41.1%
subjects with at least one TEAE potentially relate	69 18.3%
at least 1 treatment emergent SAE	14 3.7%
at least 1 treatment emergent SAE related to drug	1 0.3%
at least 1 TEAE leading to discontinuation	9 2.4%

2. Secondary Outcome

Title	Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score
Description	The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.
Time Frame	baseline, 12 weeks (LOCF)

Outcome Measure Data

Analysis Population Description

only 351 of the 377 subjects had the QIDS-SR16 assessment at week 12 (LOCF)

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone 20, 40, 60,80 mg flexible dose Lurasidone: Lurasidone 20-80 mg taken orally once daily
Measure Participants	351
Mean (Standard Deviation) [units on a scale]	-1.0 (3.23)

3. Secondary Outcome

Title	Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score
Description	The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. 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-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.
Time Frame	baseline, 12 weeks (LOCF)

Outcome Measure Data

Analysis Population Description

only 359 of the 377 subjects had the PANSS-P assessment at week 12 (LOCF)

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone 20, 40, 60,80 mg flexible dose Lurasidone: Lurasidone 20-80 mg taken orally once daily
Measure Participants	359
Mean (Standard Deviation) [units on a scale]	-0.2 (1.16)

4. Secondary Outcome

Title	Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)
Description	Movement disorders as assessed by Young Mania Rating Scale (YMRS) The YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Time Frame	Baseline, 12 weeks (LOCF)

Outcome Measure Data

Analysis Population Description

only 375 of the 377 subjects had the YMRD assessment at week 12 (LOCF)

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone 20, 40, 60,80 mg flexible dose Lurasidone: Lurasidone 20-80 mg taken orally once daily
Measure Participants	375
Mean (Standard Deviation) [units on a scale]	-1.0 (5.17)

5. Secondary Outcome

Title	Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)
Description	Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) -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 of depression.
Time Frame	baseline ,Week 12 (LOCF)

Outcome Measure Data

Analysis Population Description

Only 375 of the 377 subjects had the MADRS assessment at week 12 (LOCF)

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone 20, 40, 60,80 mg flexible dose Lurasidone: Lurasidone 20-80 mg taken orally once daily
Measure Participants	375
Mean (Standard Deviation) [units on a scale]	-1.9 (6.82)

6. Secondary Outcome

Title	Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)
Description	Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) -The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar 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	baseline, week 12 (LOCF)

Outcome Measure Data

Analysis Population Description

only 375 of the 377 subjects had the CGI-BP-S overall assessment at week 12 (LOCF)

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone 20, 40, 60,80 mg flexible dose Lurasidone: Lurasidone 20-80 mg taken orally once daily
Measure Participants	375
Mean (Standard Deviation) [units on a scale]	-.31 (1.068)

7. Secondary Outcome

Title	Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score
Description	The CGI-BP-S mania score is a single value, clinician-rated assessment of mania 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	baseline, week 12 (LOCF)

Outcome Measure Data

Analysis Population Description

Only 375 of the 377 subjects had the CGI-BP-S mania assessment at week 12 (LOCF)

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone 20, 40, 60,80 mg flexible dose Lurasidone: Lurasidone 20-80 mg taken orally once daily
Measure Participants	375
Mean (Standard Deviation) [units on a scale]	-0.13 (0.807)

8. Secondary Outcome

Title	Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale
Description	The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and range 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	baseline, week 12 (LOCF)

Outcome Measure Data

Analysis Population Description

only 375 of the 377 subjects had the CGI-BP-S depression assessment at Week 12 (LOCF)

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone 20, 40, 60,80 mg flexible dose Lurasidone: Lurasidone 20-80 mg taken orally once daily
Measure Participants	375
Mean (Standard Deviation) [units on a scale]	-0.27 (0.969)

9. Secondary Outcome

Title	Change From Baseline to Week 12 (LOCF) in the SDS Total Score
Description	The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.
Time Frame	baseline, week 12 (LOCF)

Outcome Measure Data

Analysis Population Description

only 297 of the 377 subjects had the SDS total score at week 12 (LOCF)

Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone 20, 40, 60,80 mg flexible dose Lurasidone: Lurasidone 20-80 mg taken orally once daily
Measure Participants	297
Mean (Standard Deviation) [units on a scale]	-1.4 (5.98)

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Lurasidone
Arm/Group Description	Lurasidone 20, 40, 60,80 mg flexible dose Lurasidone: Lurasidone 20-80 mg taken orally once daily
All Cause Mortality
	Lurasidone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lurasidone
	Affected / at Risk (%)	# Events
Total	14/377 (3.7%)
Blood and lymphatic system disorders
anaemia megaloblastic	1/377 (0.3%)	17
Injury, poisoning and procedural complications
craniocerebral injury	1/377 (0.3%)	1
femur fracture	1/377 (0.3%)	1
intentional overdose	1/377 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basal cell carcinoma	1/377 (0.3%)	1
Psychiatric disorders
depression	4/377 (1.1%)	4
mania	2/377 (0.5%)	2
bipolar disorder	1/377 (0.3%)	1
emotional distress	1/377 (0.3%)	1
panic attack	1/377 (0.3%)	1
persecutory delusion	1/377 (0.3%)	1
accelerated hyertension	1/377 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Lurasidone
	Affected / at Risk (%)	# Events
Total	51/377 (13.5%)
Gastrointestinal disorders
nausea	8/377 (2.1%)	9
Infections and infestations
nasopharyngitis	13/377 (3.4%)	14
Nervous system disorders
headache	15/377 (4%)	18
akathisia	12/377 (3.2%)	13
Psychiatric disorders
insomnia	11/377 (2.9%)	12

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

In the event the Study is part of a multi-center study, the first publication of the results of the study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.