A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00088634
• Collaborator: (none)
• Enrollment: 180
• Locations: 22
• Arms: 2
• Duration (Months): 7
• Patients Per Site: 8.2
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Lurasidone; Drug: Placebo	Phase 2

Detailed Description

Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-blind Fixed-dose Study of Lurasidone (SM-13496) and Placebo in the Treatment of Schizophrenia
• Study Start Date: May 1, 2004
• Actual Primary Completion Date: Dec 1, 2004
• Actual Study Completion Date: Dec 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lurasidone 80 mg AM dosing once daily	Drug: Lurasidone; 80 mg AM dosing once daily
Placebo Comparator: Placebo	Drug: Placebo; Matching Placebo to 40mg lurasidone tablets

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score [Baseline and 6 weeks]

   The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately.

Secondary Outcome Measures

1. Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores [Baseline and 6 weeks]

   The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.

2. Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores [Baseline and 6 weeks]

   The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

3. Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores [Baseline and 6 weeks]

   The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV

• The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment

• If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception

Exclusion Criteria:

• The patient has used an investigational drug within the past 30 days

• The patient has participated in a previous study of this compound

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Psychiatry Pharmaceutical	Birmingham	Alabama	United States	35209
2	Summit Research Group	Little Rock	Arkansas	United States	72211
3	Comprehensive NeuroScience	Cerritos	California	United States	90703
4	Collaborative Neuro Science Network, Inc.	Garden Grove	California	United States	92845
5	Optimum Health Services	La Mesa	California	United States	91942
6	California Clinical Trials	San Diego	California	United States	92123
7	CNRI, LLC San Diego	San Diego	California	United States	92126
8	Pacific Clinical Research	Upland	California	United States	91786
9	Comprehensive NeuroScience, Inc	Washington	District of Columbia	United States	20016
10	Segal Institute for Clinical Research	North Miami	Florida	United States	33161
11	The Segal Institute	North Miami	Florida	United States	33161
12	University of South Florida, Department of Psychiatry and Behavioral Medicine	Tampa	Florida	United States	33613
13	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30308
14	Comprehensive Neuroscience, Inc.	Hoffman Estates	Illinois	United States	60194
15	Robert Lynn Horne, MD, Suite 4	Las Vegas	Nevada	United States	89102
16	CNS Research Institute	Clementon	New Jersey	United States	08021
17	Quantum Clinical Services Group	Philadelphia	Pennsylvania	United States	19139
18	Community Clinical Research	Austin	Texas	United States	78729
19	Future Search Trials	Austin	Texas	United States	78756
20	Claghorn-Lesem Research Clinic	Bellaire	Texas	United States	77401
21	InSite Clinical Research	DeSoto	Texas	United States	75115
22	CBH Health, L.L.C - Dominion Hospital	Falls Church	Virginia	United States	22044

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: NCT00088634
• Other Study ID Numbers: D1050196
• First Posted: Aug 2, 2004
• Last Update Posted: Apr 8, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Sunovion: Schizophrenia; Latuda; Lurasidone
• Additional relevant MeSH terms: Schizophrenia; Lurasidone Hydrochloride

Study Results

Participant Flow

Arm/Group Title	Lurasidone 80 mg	Placebo
Arm/Group Description	2 40 mg lurasidone tablets taken once/day	Matching placebo to lurasidone 40 mg tablets taken once/day
Period Title: Overall Study
STARTED	90	90
COMPLETED	52	47
NOT COMPLETED	38	43

Baseline Characteristics

Arm/Group Title	Lurasidone 80 mg	Placebo	Total
Arm/Group Description	2 40 mg lurasidone tablets taken once/day	Matching placebo to lurasidone 40 mg tablets taken once/day	Total of all reporting groups
Overall Participants	90	90	180
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.7 (9.91)	41.9 (9.78)	40.8 (9.88)
Sex: Female, Male (Count of Participants)
Female	22 24.4%	20 22.2%	42 23.3%
Male	68 75.6%	70 77.8%	138 76.7%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score
Description	The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately.
Time Frame	Baseline and 6 weeks

Outcome Measure Data

Analysis Population Description

Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.

Arm/Group Title	Lurasidone 80 mg	Placebo
Arm/Group Description	2 40 mg lurasidone tablets taken once/day	Matching placebo to lurasidone 40 mg tablets taken once/day
Measure Participants	90	90
Least Squares Mean (95% Confidence Interval) [units on a scale]	-8.9	-4.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lurasidone 80 mg, Placebo
	Comments	Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline BPRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
Description	The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.
Time Frame	Baseline and 6 weeks

Outcome Measure Data

Analysis Population Description

Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS

Arm/Group Title	Lurasidone 80 mg	Placebo
Arm/Group Description	2 40 mg lurasidone tablets taken once/day	Matching placebo to lurasidone 40 mg tablets taken once/day
Measure Participants	90	90
Least Squares Mean (95% Confidence Interval) [units on a scale]	-14.1	-5.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lurasidone 80 mg, Placebo
	Comments	Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline PANSS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANCOVA
	Comments

3. Secondary Outcome

Title	Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
Description	The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time Frame	Baseline and 6 weeks

Outcome Measure Data

Analysis Population Description

Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.

Arm/Group Title	Lurasidone 80 mg	Placebo
Arm/Group Description	2 40 mg lurasidone tablets taken once/day	Matching placebo to lurasidone 40 mg tablets taken once/day
Measure Participants	90	90
Least Squares Mean (95% Confidence Interval) [units on a scale]	-0.6	-0.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lurasidone 80 mg, Placebo
	Comments	Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline CGI-S score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANCOVA
	Comments

4. Secondary Outcome

Title	Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
Description	The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Time Frame	Baseline and 6 weeks

Outcome Measure Data

Analysis Population Description

Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.

Arm/Group Title	Lurasidone 80 mg	Placebo
Arm/Group Description	2 40 mg lurasidone tablets taken once/day	Matching placebo to lurasidone 40 mg tablets taken once/day
Measure Participants	86	83
Least Squares Mean (95% Confidence Interval) [units on scale]	-2.9	-0.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lurasidone 80 mg, Placebo
	Comments	Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline MADRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Arm/Group Title	Lurasidone 80 mg		Placebo
Arm/Group Description	2 40 mg lurasidone tablets taken once/day		Matching placebo to lurasidone 40 mg tablets taken once/day
All Cause Mortality
	Lurasidone 80 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lurasidone 80 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/90 (2.2%)		3/90 (3.3%)
Investigations
Blood Creatine Phosphokinase Increased	0/90 (0%)	0	1/90 (1.1%)	1
Psychiatric disorders
Schizophrenia NOS	2/90 (2.2%)	2	1/90 (1.1%)	1
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airways Disease	0/90 (0%)	0	1/90 (1.1%)	1
Other (Not Including Serious) Adverse Events
	Lurasidone 80 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	53/90 (58.9%)		37/90 (41.1%)
Gastrointestinal disorders
Constipation	10/90 (11.1%)	10	5/90 (5.6%)	5
Dyspepsia	7/90 (7.8%)	7	3/90 (3.3%)	3
Nausea	15/90 (16.7%)	15	3/90 (3.3%)	3
Toothache	5/90 (5.6%)	5	3/90 (3.3%)	3
Vomiting	10/90 (11.1%)	10	5/90 (5.6%)	5
Infections and infestations
Upper Respiratory Tract Infection	3/90 (3.3%)	3	6/90 (6.7%)	6
Musculoskeletal and connective tissue disorders
Back Pain	3/90 (3.3%)	3	5/90 (5.6%)	5
Nervous system disorders
Akathisia	8/90 (8.9%)	8	3/90 (3.3%)	3
Headache	10/90 (11.1%)	10	9/90 (10%)	9
Sedation	9/90 (10%)	9	4/90 (4.4%)	4
Somnolence	10/90 (11.1%)	10	3/90 (3.3%)	3
Psychiatric disorders
Anxiety	6/90 (6.7%)	6	1/90 (1.1%)	1
Insomnia	9/90 (10%)	9	3/90 (3.3%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.