PEARL 3 Ext: Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00789698
• Collaborator: (none)
• Enrollment: 240
• Locations: 65
• Arms: 2
• Duration (Months): 30.9
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.

Condition or Disease	Intervention/Treatment	Phase
Chronic Schizophrenia	Drug: Lurasidone HC1; Drug: Quetiapine XR	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Lurasidone in Subjects With Schizophrenia (PEARL 3 Extension Study)
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lurasidone HC1	Drug: Lurasidone HC1; Lurasidone 40-160 mg/day flexibly dosed.
Active Comparator: Quetiapine	Drug: Quetiapine XR; Quetiapine XR 200-800 mg/day flexibly dosed.

Outcome Measures

Primary Outcome Measures

1. Relapse of Psychotic Symptoms [12 Months]

   Time to relapse will be defined as the earliest occurrence of any of the following: Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3 rehospitalization for worsening of psychosis emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate.

Secondary Outcome Measures

1. Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores. [Baseline and 6 Months]

   The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.

2. Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS) [Baseline and 12 months]

   The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).

3. Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores [Baseline and 12 months]

   The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.

Eligibility Criteria

Criteria

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

Entry Criteria:

• Screening for the present study will take place after subjects' participation in Study D1050233 has been completed, and after providing informed consent.

Inclusion Criteria:

• Completed all required assessments on the final study visit in Study D1050233.

• Suitable for treatment in an outpatient setting.

Exclusion Criteria:

• Any chronic organic disease of the CNS (other than schizophrenia).

• Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	K&S Professional Research Services, LLC	Little Rock	Arkansas	United States	72201
2	Woodland International Research Group	Little Rock	Arkansas	United States	72211
3	Comprehensive Neuroscience, Inc	Cerritos	California	United States	90703
4	Clinical Innovations, Inc.	Costa Mesa	California	United States	92647
5	Synergy Escondido,710 East Grand Ave.	Escondido	California	United States	92025
6	Collaborative Neuroscience Network Inc	Garden Grove	California	United States	92645
7	Apostle Clinical Trials, Inc.	Long Beach	California	United States	90813
8	California Clinical Trials	Paramount	California	United States	90723
9	Pasadena Research Institute	Pasadena	California	United States	91107
10	CNRI - Los Angeles LLC,8309 Telegraph Road	Pico Rivera	California	United States	90660
11	CNRI- LOs Angeles, LLC	Pico Rivera	California	United States	90660
12	Clinical Innovations, Inc.	Riverside	California	United States	92647
13	CNRI - San Diego	San Diego	California	United States	92102
14	UCSD Medical Drive	Sandeigo	California	United States	92103
15	Segal Institute for Clinical Research	Highlands Ranch	Colorado	United States	80103
16	Comprehensive Neuroscience, Inc.	Washington	District of Columbia	United States	20016
17	Florida Clinical Research Center LLC	Bradenton	Florida	United States	34208
18	Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340	Lake Charles	Louisiana	United States	70601
19	Booker, J. Gary, MD. APMC	Shreveport	Louisiana	United States	71104
20	St. Charles Psychiatric Associates	St. Charles	Missouri	United States	63301
21	St. Louis Research, Inc.	St. Louis	Missouri	United States	63118
22	CRI Worldwide	Willingboro	New Jersey	United States	08046
23	SUNY Downstate Medical Center	Brooklyn	New York	United States	11238
24	Comprehensive Neuroscience, Inc	Holliswood	New York	United States	11423
25	Community Clinical Research	Austin	Texas	United States	78729
26	FutureSearch Clinical Trials, LLC.	Austin	Texas	United States	78756
27	Pillar Clinical Research	Dallas	Texas	United States	75243
28	CIPNA Centro de Investigaciones y Proyectos en Neurociencias	Calle 80#47-43 Consultorio 5C	Barranquila S/N	Colombia
29	Centro de Investigacion y Atencion para la Salud Mental	Calle 103A # 21-49	Bogota S/N	Colombia
30	Centro de Investigaciones y Proyectos en Neurociencias CIPNA	Barranquilla		Colombia
31	Centro de Investigación y Atención para la Salud Mental	Bogota		Colombia
32	CISNE - UIC Campo Abierto	Bogota		Colombia
33	Instituto Colombiano del Sistema Nervioso Clínica Montserrat	Bogota		Colombia
34	Vijayawada Institute of Mental Health and Neurosciences	Vijayawada	Andhra Pradesh	India	520002
35	S.V. Medical College	Tirupati	Andra Pradesh	India	517507
36	Shanti Nursing Home	Kanchanpalli	Aurangabad, Maharashtra	India
37	Seth K M School of P G Medicine & Research	Ahmedabad	Gujarat	India	380006
38	SBKS Medical College and Hospital, Brij Psychiatry Hospital	Vadodara	Gujarat	India	390001
39	Justice K.S. Hedge Charitable Hospital	Mangalore	Karna	India	574160
40	JSS Medical College and Hospital - Dept of Psychiatry	Mysore	Karna	India	570004
41	Mahatma Gandhi Institute of Medical Sciences	Sewagram	Maharashtra	India
42	Deenanath Mangeshkar Hospital and Research Centre	Pune	Maharastra	India	411004
43	Madras Medical College & Government General Hospital	Chennai	TamilNadu	India	600003
44	Spitalul Clinic Judetean de Urgenta Arad	Str. Octavian Goga nr. 17	Arad	Romania	310022
45	Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia	Sos. Berceni nr. 10-12	Bucuresti	Romania	041914
46	Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia	Bucuresti		Romania
47	Spitalul Clinic de Neurologie si Psihiatrie Oradea	Oradea		Romania
48	Spitalul Judetean Arges	Pitesti		Romania	110069
49	Andreev, Boris	Gatchina		Russian Federation
50	Gurovich, Isaak	Moscow		Russian Federation
51	Morozova, Margarita	Moscow		Russian Federation
52	Sheifer, Mikhail	Samara		Russian Federation
53	City Psychoneurological Dispensary #7 (with Hospital)	St-Petersburg		Russian Federation	190005
54	City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets	St. Petersburg		Russian Federation	190121
55	City Psychiatric Hospital #4	St. Petersburg		Russian Federation	191119
56	City Psychiatric Hospital #3 of Skvortsov-Stepanov	St. Petersburg		Russian Federation	197341
57	Neznanov, Nikolay	St. Petersburg		Russian Federation
58	Dnipropetrovsk Regional Clinical Hospital named Mechnikov	Dnipropetrovsk		Ukraine	49005
59	Reg.Clin.Psychiatric Hosp., Dept. #11, DSMU n.af.M.Gorkiy	Donetsk		Ukraine	83037
60	Kyiv City Clin. Psychoneurolog. Hosp.#1	Kyiv		Ukraine	04080
61	Kyiv City Psychoneurological Hospital	Kyviv		Ukraine
62	Lviv Reg.St.Cl.Psych.Hosp	Lviv		Ukraine
63	Reg. Psychiatric Hospital	Odessa		Ukraine
64	Crimean republican Clinical Psychiatric Hospital	Simferopol		Ukraine
65	Kherson Regional Psychiatric Hospital	vil. Stepanovka, Kherson		Ukraine	73488

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: NCT00789698
• Other Study ID Numbers: D1050234
• First Posted: Nov 13, 2008
• Last Update Posted: Jun 12, 2015
• Last Verified: May 1, 2015

• Keywords provided by Sunovion: Schizophrenia; SM-13496; Latuda; Lurasidone
• Additional relevant MeSH terms: Schizophrenia; Quetiapine Fumarate; Lurasidone Hydrochloride

Study Results

Participant Flow

Pre-assignment Detail	Patients transitioned from the acute phase study (D1050233 -NCT00790192) to the current study (D1050234) in a non-randomized fashion.

Arm/Group Title	Lurasidone 80mg	Lurasidone 160 mg	Placebo-Lurasidone	Quetiapine-Quetiapine
Arm/Group Description	Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.	Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.	Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study	Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
Period Title: Overall Study
STARTED	72	79	56	85
COMPLETED	32	46	29	33
NOT COMPLETED	40	33	27	52

Baseline Characteristics

Arm/Group Title	Lurasidone 80mg	Lurasidone 160 mg	Placebo-Lurasidone	Quetiapine-Quetiapine	Total
Arm/Group Description	Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.	Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.	Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study	Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study	Total of all reporting groups
Overall Participants	72	79	56	85	292
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.6 (11.7)	37.6 (11.7)	37.5 (11.4)	38.5 (10.4)	37.6 (11.3)
Sex: Female, Male (Count of Participants)
Female	16 22.2%	27 34.2%	21 37.5%	33 38.8%	97 33.2%
Male	56 77.8%	52 65.8%	35 62.5%	52 61.2%	195 66.8%
Region of Enrollment (participants) [Number]
United States	18 25%	15 19%	14 25%	23 27.1%	70 24%
Ukraine	17 23.6%	15 19%	9 16.1%	18 21.2%	59 20.2%
Romania	6 8.3%	9 11.4%	2 3.6%	10 11.8%	27 9.2%
Russian Federation	11 15.3%	15 19%	12 21.4%	17 20%	55 18.8%
Colombia	5 6.9%	3 3.8%	3 5.4%	4 4.7%	15 5.1%
India	15 20.8%	22 27.8%	16 28.6%	13 15.3%	66 22.6%

Outcome Measures

1. Primary Outcome

Title	Relapse of Psychotic Symptoms
Description	Time to relapse will be defined as the earliest occurrence of any of the following: Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3 rehospitalization for worsening of psychosis emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

The population for relapse analyses is the relapse population which consists of those subjects who are enrolled in the present study, demonstrated response to 6 weeks of treatment with either lurasidone or quetiapine XR in study D1050233-NCT 00790192, and who took at least one dose of study medication in the present study.

Arm/Group Title	Lurasidone-Lurasidone	Quetiapine-Quetiapine
Arm/Group Description	Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.	Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
Measure Participants	139	79
Number [participants]	29 40.3%	21 26.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lurasidone-Lurasidone, Quetiapine-Quetiapine
	Comments	Comparison of time to relapse of psychotic symptoms between LUR-LUR and QXR-QXR as analyzed using the Cox proportional-hazards model.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	This is a non-inferiority analysis. Lurasidone will be declared as effective as quetiapine XR in preventing relapse if the upper bound of a 2-sided 95% confidence limit for the hazard ration of lurasidone vs. quetiapine is no greater than an equivalence hazard ratio margin of 1.93.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.728
	Confidence Interval	(2-Sided) 95%; 0.410 to 1.295
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.
Description	The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.
Time Frame	Baseline and 6 Months

Outcome Measure Data

Analysis Population Description

The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements

Arm/Group Title	Lurasidone-Lurasidone	Quetiapine-Quetiapine
Arm/Group Description	Lurasidone 80 mg/day or Lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.	Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
Measure Participants	86	41
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.22	-0.03

3. Secondary Outcome

Title	Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)
Description	The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements

Arm/Group Title	Lurasidone-Lurasidone	Quetiapine-Quetiapine
Arm/Group Description	Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.	Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
Measure Participants	132	72
Least Squares Mean (95% Confidence Interval) [units on a scale]	-34.6	-25.7

4. Secondary Outcome

Title	Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores
Description	The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements

Arm/Group Title	Lurasidone-Lurasidone	Quetiapine-Quetiapine
Arm/Group Description	Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.	Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
Measure Participants	132	72
Least Squares Mean (95% Confidence Interval) [units on a scale]	-1.9	-1.6

Adverse Events

Arm/Group Title	Lurasidone 80mg		Lurasidone 160 mg		Placebo-Lurasidone		Quetiapine-Quetiapine
Arm/Group Description	Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.		Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.		Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study		Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
All Cause Mortality
	Lurasidone 80mg		Lurasidone 160 mg		Placebo-Lurasidone		Quetiapine-Quetiapine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Lurasidone 80mg		Lurasidone 160 mg		Placebo-Lurasidone		Quetiapine-Quetiapine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/72 (12.5%)		6/79 (7.6%)		2/56 (3.6%)		17/85 (20%)
Cardiac disorders
Acute Myocardial Infarction	0/72 (0%)	0	0/79 (0%)	0	0/56 (0%)	0	1/85 (1.2%)	1
Cardiomyopathy	0/72 (0%)	0	0/79 (0%)	0	0/56 (0%)	0	1/85 (1.2%)	1
Hepatobiliary disorders
Cholelithiasis	0/72 (0%)	0	0/79 (0%)	0	1/56 (1.8%)	1	0/85 (0%)	0
Injury, poisoning and procedural complications
Lower Limb Fracture	0/72 (0%)	0	1/79 (1.3%)	1	0/56 (0%)	0	0/85 (0%)	0
Skeletal Injury	0/72 (0%)	0	1/79 (1.3%)	1	0/56 (0%)	0	0/85 (0%)	0
Nervous system disorders
Parkinsonism	0/72 (0%)	0	1/79 (1.3%)	1	0/56 (0%)	0	0/85 (0%)	0
Psychiatric disorders
Agitation	0/72 (0%)	0	1/79 (1.3%)	1	0/56 (0%)	0	2/85 (2.4%)	2
Completed Suicide	1/72 (1.4%)	1	0/79 (0%)	0	0/56 (0%)	0	0/85 (0%)	0
Psychotic Disorder	3/72 (4.2%)	3	2/79 (2.5%)	2	0/56 (0%)	0	6/85 (7.1%)	6
Schizophrenia	3/72 (4.2%)	3	1/79 (1.3%)	1	1/56 (1.8%)	1	9/85 (10.6%)	9
Schizophrenia, paranoid type	1/72 (1.4%)	1	0/79 (0%)	0	0/56 (0%)	0	0/85 (0%)	0
Suicidal Behavior	1/72 (1.4%)	1	0/79 (0%)	0	0/56 (0%)	0	0/85 (0%)	0
Other (Not Including Serious) Adverse Events
	Lurasidone 80mg		Lurasidone 160 mg		Placebo-Lurasidone		Quetiapine-Quetiapine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	44/72 (61.1%)		51/79 (64.6%)		35/56 (62.5%)		53/85 (62.4%)
Gastrointestinal disorders
Diarrhoea	2/72 (2.8%)	2	2/79 (2.5%)	2	4/56 (7.1%)	4	4/85 (4.7%)	4
Nausea	3/72 (4.2%)	3	4/79 (5.1%)	4	6/56 (10.7%)	6	2/85 (2.4%)	3
Toothache	0/72 (0%)	0	1/79 (1.3%)	1	3/56 (5.4%)	3	3/85 (3.5%)	5
Vomiting	3/72 (4.2%)	8	3/79 (3.8%)	4	3/56 (5.4%)	4	4/85 (4.7%)	7
Investigations
Weight Increased	3/72 (4.2%)	6	6/79 (7.6%)	6	1/56 (1.8%)	1	7/85 (8.2%)	8
Nervous system disorders
Akathisia	11/72 (15.3%)	16	8/79 (10.1%)	9	6/56 (10.7%)	9	2/85 (2.4%)	3
Dystonia	4/72 (5.6%)	7	1/79 (1.3%)	1	2/56 (3.6%)	6	1/85 (1.2%)	1
Headache	5/72 (6.9%)	7	11/79 (13.9%)	16	3/56 (5.4%)	5	8/85 (9.4%)	11
Parkinsonism	3/72 (4.2%)	5	6/79 (7.6%)	7	9/56 (16.1%)	12	0/85 (0%)	0
Somnolence	1/72 (1.4%)	1	4/79 (5.1%)	4	1/56 (1.8%)	1	4/85 (4.7%)	4
Psychiatric disorders
Anxiety	3/72 (4.2%)	3	6/79 (7.6%)	6	2/56 (3.6%)	3	3/85 (3.5%)	4
Insomnia	5/72 (6.9%)	5	7/79 (8.9%)	8	4/56 (7.1%)	4	8/85 (9.4%)	9
Schizophrenia	5/72 (6.9%)	6	2/79 (2.5%)	2	2/56 (3.6%)	2	13/85 (15.3%)	16

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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 following completion of study at all sites, the PI shall be free to publish.