RESOLVE 1: Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01421134
• Collaborator: (none)
• Enrollment: 211
• Locations: 43
• Arms: 2
• Duration (Months): 37
• Patients Per Site: 4.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder With Mixed Features	Drug: Lurasidone; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 211 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lurasidone Lurasidone 20, 40 or 60 mg	Drug: Lurasidone; 20, 40, 60 mg, flexible dose, once daily PM 6 weeks; Other Names: Latuda
Placebo Comparator: Placebo Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores [Baseline to Week 6]

   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.

Secondary Outcome Measures

1. Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score [Baseline to Week 6]

   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.

2. Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score [Baseline to Week 6]

   The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.

3. Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score [Baseline to Week 6]

   The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).

4. Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score [Baseline to Week 6]

   The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.

5. Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF). [Baseline to Week 6]

6. Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF) [Baseline to Week 6]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.

• Subject is 18 to 75 years of age, inclusive.

• Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]).

• Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304):

• Elevated, expansive mood

• Inflated self-esteem or grandiosity

• More talkative than usual or pressure to keep talking

• Flight of ideas or subjective experience that thoughts are racing

• Increase in energy or goal-directed activity (either socially, at work or school, or sexually)

• Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)

• Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia)

Exclusion Criteria:

• Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening.

• Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.

• Subject has attempted suicide within the past 3 months.

• Subject has a lifetime history of any bipolar I manic or mixed manic episode.

• Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Psychiatry Pharmaceutical Studies, Inc.	Birmingham	Alabama	United States	35226
2	Synergy Clinical Research Center	Escondido	California	United States	92025
3	Collaborative Neuroscience Network Inc.	Garden Grove	California	United States	92845
4	Stanford -VA Palo Alto Health Care System	Palo Alto	California	United States	94304
5	Clinical Innovations Inc.	Riverside	California	United States	92506
6	Artemis Institute for Clinical Research	San Diego	California	United States	92123
7	Florida Clinical Research Center, LLC	Sarasota	Florida	United States	34201
8	Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders	Boston	Massachusetts	United States	02114
9	St. Charles Psychiatric Associates/Midwest Research Group	St. Charles	Missouri	United States	63301
10	Social Psychiatric Research Inst. (SPRI) Clinical Trials	Brooklyn	New York	United States	11235
11	Village Clinical Research Inc.	New York	New York	United States	10003
12	Finger Lakes Clinical Research	Rochester	New York	United States	14618
13	Behavioral Medical Research of Staten Island	Staten Island	New York	United States	10305
14	Psychiatry and Behavioral Sciences, Duke	Durham	North Carolina	United States	27705
15	Midwest Clinical Research Center	Dayton	Ohio	United States	45417
16	CRI Worldwide - Kirkbride	Philadelphia	Pennsylvania	United States	19139
17	FutureSearch Trials of Dallas, LP	Dallas	Texas	United States	75231
18	Dept. of Psychiatry, UT Southwestern Medical Center	Dallas	Texas	United States	75390-8849
19	Grayline Clinical Drug Trials	Wichita Falls	Texas	United States	76309
20	Municipal Healthcare Institution"City Clinical Hospital #2, n.a. V.I. Razumovsky" of Healthcare Committee of Administration of Municipal Entity "City of Saratov"	Saratov		Russian Federation	410028
21	State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia,	Saratov		Russian Federation	410060
22	Saint Nicholas Psychiatric Hospital.	St. Petersburg		Russian Federation	190121
23	City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit)	St. Petersburg		Russian Federation	191119
24	Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva"	St. Petersburg		Russian Federation	193167
25	Limited Liability Company "Research-And-Educational Centre of Psychotherapy "Podderzhka"	Stavropol		Russian Federation	355000
26	Institute of Mental Health	Belgrade		Serbia	11000
27	Psychiatric Clinic, Clinical Hospital Center"Dr. Dragisa Misovic-Dedinje"	Belgrade		Serbia	11000
28	Health Centre Cacak Department of Psychiatry	Cacak		Serbia	32000
29	Clinical Center Nis, Psychiatric Clinic	Gornja Toponica		Serbia	18201
30	Clinical Center Kragujevac, Psychiatric Clinic	Kragujevac		Serbia	34000
31	Clinic for Mental Health, Clinical Center Nis	Nis		Serbia	18000
32	Special Hospital for Psychiatric Diseases "Sveti Vracevi"	Vojvodina		Serbia	23330
33	Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"	Vrsac		Serbia	26300
34	General Hospital "Djordje Joanovic" Psychiatric Dept.	Zrenjanin		Serbia	23000
35	Dnipropetrovsk Regional Clinical Hospital named Mechnikov	Dnipropetrovsk		Ukraine	49005
36	State Institution "Institute of Neurology, Psychiatry and Narcology NAMS of Ukraine", Dep. of Clinical, Social and Child Psychiatry	Kharkiv		Ukraine	61068
37	Communal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association "Psychiatric Dept. #10 and Psychiatric Dept. #2	Kyiv		Ukraine	08631
38	"Lugansk State Medical University"Chair of Psychiatry, Narcology and Medical Psychology; Lugansk Regional Clinical Psychoneurological Hospital, Dispensary Dept. for adults	Lugansk		Ukraine	91045
39	Municipal Institution "Lviv Regional State Clinical Psychiatric Hospital, Department #20	Lviv		Ukraine	79021
40	Odesa Regional Psychoneurological Dispensary, Outpatient Dept.	Odesa		Ukraine	65014
41	Vinnytsya National Medical University n.a. M.I. Pyrogov, Dept. of Psychiatry and Narcology, Vinnytsya Regional Psychoneurological Hospital n.a. O.I. Yushchenko, Dept. no. 14, Dept. no 15	Vinnytsya		Ukraine	21018
42	MAC Clinical Research Limited	Cannock		United Kingdom	WS11 0BN
43	MAC Clinical Research Limited	Manchester		United Kingdom	M32 0UT

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: NCT01421134
• Other Study ID Numbers: D1050304
• First Posted: Aug 22, 2011
• Last Update Posted: Jul 15, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Sunovion: depression; Lurasidone; Latuda
• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Lurasidone Hydrochloride

Study Results

Participant Flow

Arm/Group Title	Lurasidone	Placebo
Arm/Group Description	Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks	Placebo Placebo: Placebo
Period Title: Overall Study
STARTED	109	102
COMPLETED	102	87
NOT COMPLETED	7	15

Baseline Characteristics

Arm/Group Title	Lurasidone	Placebo	Total
Arm/Group Description	Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks	Placebo Placebo: Placebo	Total of all reporting groups
Overall Participants	109	100	209
Age (Count of Participants)
<=18 years	1 0.9%	0 0%	1 0.5%
Between 18 and 65 years	106 97.2%	96 96%	202 96.7%
>=65 years	2 1.8%	4 4%	6 2.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.6 (12.08)	46.4 (12.01)	44.9 (12.10)
Sex: Female, Male (Count of Participants)
Female	73 67%	72 72%	145 69.4%
Male	36 33%	28 28%	64 30.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 1%	1 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	14 12.8%	12 12%	26 12.4%
White	94 86.2%	86 86%	180 86.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 0.9%	1 1%	2 1%
Region of Enrollment (participants) [Number]
Russian Federation	18 16.5%	13 13%	31 14.8%
United States	34 31.2%	26 26%	60 28.7%
Ukraine	30 27.5%	32 32%	62 29.7%
United Kingdom	1 0.9%	3 3%	4 1.9%
Serbia	26 23.9%	26 26%	52 24.9%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores
Description	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.
Time Frame	Baseline to Week 6

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	Lurasidone	Placebo
Arm/Group Description	Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks	Placebo Placebo: Placebo
Measure Participants	108	100
Least Squares Mean (Standard Error) [units on a scale]	-20.5 (0.95)	-13.0 (1.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lurasidone, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-7.5
	Confidence Interval	(2-Sided) 95%; -10.2 to -4.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.37
	Estimation Comments

2. Secondary Outcome

Title	Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score
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	Baseline to Week 6

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	Lurasidone	Placebo
Arm/Group Description	Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks	Placebo Placebo: Placebo
Measure Participants	108	100
Least Squares Mean (Standard Error) [units on a scale]	-1.83 (0.109)	-1.18 (0.115)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lurasidone, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95%; -0.96 to -0.34
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.157
	Estimation Comments

3. Secondary Outcome

Title	Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score
Description	The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Time Frame	Baseline to Week 6

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	Lurasidone	Placebo
Arm/Group Description	Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks	Placebo Placebo: Placebo
Measure Participants	108	100
Least Squares Mean (Standard Error) [units on a scale]	-7.0 (0.35)	-4.9 (0.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lurasidone, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-2.1
	Confidence Interval	(2-Sided) 95%; -3.1 to -1.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.50
	Estimation Comments

4. Secondary Outcome

Title	Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score
Description	The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).
Time Frame	Baseline to Week 6

Outcome Measure Data

Analysis Population Description

Intent to treat population: 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.

Arm/Group Title	Lurasidone	Placebo
Arm/Group Description	Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks	Placebo Placebo: Placebo
Measure Participants	70	69
Least Squares Mean (Standard Error) [units on a scale]	-11.2 (0.88)	-6.4 (0.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lurasidone, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-4.8
	Confidence Interval	(2-Sided) 95%; -7.2 to -2.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.21
	Estimation Comments

5. Secondary Outcome

Title	Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score
Description	The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.
Time Frame	Baseline to Week 6

Outcome Measure Data

Analysis Population Description

Intent to treat population. 3 Lurasidone subjects and 2 placebo subjects did not have post-baseline HAM-A assessment.

Arm/Group Title	Lurasidone	Placebo
Arm/Group Description	Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks	Placebo Placebo: Placebo
Measure Participants	105	98
Least Squares Mean (Standard Error) [units on a scale]	-9.9 (0.58)	-5.4 (0.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lurasidone, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-4.5
	Confidence Interval	(2-Sided) 95%; -6.1 to -2.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.81
	Estimation Comments

6. Secondary Outcome

Title	Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).
Time Frame	Baseline to Week 6

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	Lurasidone	Placebo
Arm/Group Description	Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks	Placebo Placebo: Placebo
Measure Participants	108	100
Number [percentage of subjects]	64.8	30.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lurasidone, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	6.615
	Confidence Interval	(2-Sided) 95%; 3.251 to 13.459
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds Ratio was based on a logistic regression of response, with treatment group, baseline MADRS total score, and pooled center as fixed effects.

7. Secondary Outcome

Title	Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)
Time Frame	Baseline to Week 6

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	Lurasidone	Placebo
Arm/Group Description	Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks	Placebo Placebo: Placebo
Measure Participants	108	100
Number [percentage of subjects]	49.1	23.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lurasidone, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.270
	Confidence Interval	(2-Sided) 95%; 2.105 to 8.663
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	6 Weeks
Arm/Group Title	Lurasidone		Placebo
Arm/Group Description	Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks		Placebo Placebo: Placebo
All Cause Mortality
	Lurasidone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lurasidone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/109 (0.9%)		0/100 (0%)
Psychiatric disorders
Depression Suicidal	1/109 (0.9%)	1	0/100 (0%)	0
Other (Not Including Serious) Adverse Events
	Lurasidone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	31/109 (28.4%)		29/100 (29%)
Gastrointestinal disorders
Nausea	7/109 (6.4%)	7	2/100 (2%)	2
Abdominal discomfort	4/109 (3.7%)	5	1/100 (1%)	1
Dry mouth	3/109 (2.8%)	3	1/100 (1%)	1
Infections and infestations
Urinary Tract Infection	1/109 (0.9%)	1	2/100 (2%)	3
Injury, poisoning and procedural complications
Contusion	0/109 (0%)	0	2/100 (2%)	2
Nervous system disorders
Headache	6/109 (5.5%)	6	6/100 (6%)	7
Somnoelence	5/109 (4.6%)	6	1/100 (1%)	1
Akathisia	4/109 (3.7%)	4	2/100 (2%)	2
Dizziness	4/109 (3.7%)	5	3/100 (3%)	3
Psychiatric disorders
Insomnia	6/109 (5.5%)	7	11/100 (11%)	11
Anxiety	4/109 (3.7%)	4	9/100 (9%)	12
Renal and urinary disorders
Haemarturia	0/109 (0%)	0	2/100 (2%)	2
Skin and subcutaneous tissue disorders
Pruritus	1/109 (0.9%)	1	2/100 (2%)	2

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.