Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represents the change from baseline to last observation after baseline in Composite T-Score.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated.

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.

Time frame: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch).

Time frame: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who had a baseline and at least one post-baseline assessment by actigraphy

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in maximum activity to Endpoint.

Time frame: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to endpoint in standard deviation of activity (counts/epoch).

Time frame: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.

Time frame: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.

Time frame: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.

Time frame: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 1 in the ESS total score.

Time frame: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 1.

Time frame: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.

Time frame: Baseline and Week 1

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch)to Week 1.

Time frame: Baseline and Week 1

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in maximum activity.

Time frame: Baseline and Week 1

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in standard deviation of activity (counts/epoch).

Time frame: Baseline and Week 1

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.

Time frame: Baseline and Week 1

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in total activity.

Time frame: Baseline and Week 1

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 1.

Time frame: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 1.

Time frame: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 2 in the ESS total score.

Time frame: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 2.

Time frame: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.

Time frame: Baseline and Week 2

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 2.

Time frame: Baseline and Week 2

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in maximum activity.

Time frame: Baseline and Week 2

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in standard deviation of activity (counts/epoch).

Time frame: Baseline and Week 2

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.

Time frame: Baseline and Week 2

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.

Time frame: Baseline and Week 2

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 2.

Time frame: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 2.

Time frame: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

n The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.

Time frame: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.

Time frame: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.

Time frame: Baseline and Week 3

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 3.

Time frame: Baseline and Week 3

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in maximum activity.

Time frame: Baseline and Week 3

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in standard deviation of activity (counts/epoch).

Time frame: Baseline and Week 3

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.

Time frame: Baseline and Week 3

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.

Time frame: Baseline and Week 3

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3

ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 4 in the ESS total score.

Time frame: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in composite T-score from baseline to 4 weeks.

Time frame: Baseline and 4 weeks

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had a MATRICS efficacy assessment at baseline and at Week 4. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated.

SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 4.

Time frame: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.

Time frame: Baseline and Week 4

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 4.

Time frame: Baseline and Week 4

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in maximum activity.

Time frame: Baseline and Week 4

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in standard deviation of activity (counts/epoch).

Time frame: Baseline and Week 4

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.

Time frame: Baseline and Week 4

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in total activity.

Time frame: Baseline and Week 4

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 4.

Time frame: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 4.

Time frame: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.

Time frame: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.

Time frame: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Endpoint.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline

The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Attention/Vigilance Domain T-score from baseline to last observation after baseline.

Time frame: Baseline and 4 weeks (or last observation after baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The BASC SC Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in BASC SC Test T-score from baseline to last observation after baseline.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Fluency Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Fluency Test T-score from baseline to last observation after baseline.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The LNS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in LNS T-score from baseline to last observation after baseline.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Endpoint.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline

The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Reasoning and Problem Solving Domain T-score from baseline to last observation after baseline.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at least once after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Social Cognition Domain T-score from baseline to last observation after baseline.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Processing Speed Domain T-score from baseline to last observation after baseline.

Time frame: Baseline 4 weeks (or last observation after baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Trail Making Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Trail Making Test T-score from baseline to last observation after baseline.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

Trail B is an instrument designed to assess set shifting. The patient was given a paper with numbers and letters on it and asked to connect them in an alternating manner (eg. 1-A-2-B-3C). The time required for the patient to complete the test was recorded. The change from Baseline to last observation following Baseline in the time necessary to complete the test is presented here.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Verbal Learning Domain T-score from baseline to last observation after baseline.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Visual Learning Domain T-score from baseline to last observation after baseline.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The WMS-III SS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in WMS-III SS T-score from baseline to last observation after baseline.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of sorting categories achieved was assessed.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of consecutive responses on the final category was assessed.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules during the test. Perseveration errors occur when subject repeats the same error no matter how many times they are told the placement is wrong. The change from baseline in number of perseveration errors was assessed.

Time frame: 4 weeks (or last observation after baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Working Memory Domain T-score from baseline to last observation after baseline.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Endpoint (Week 4 or last observation following baseline) in the ESS total score.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Endpoint.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Baseline.

Time frame: Baseline

Population: Full analysis set defined as the number of subjects who had at least one observation after baseline

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 1.

Time frame: Baseline and 1 week

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 2.

Time frame: Baseline and 2 weeks

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 4.

Time frame: Baseline and 4 weeks

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Endpoint which is Week 4 or the last observation following Baseline.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as the number of subjects who had at least one observation after baseline

The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 1 is presented here.

Time frame: Week 1

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 2 is presented here.

Time frame: Week 2

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 is presented here.

Time frame: Week 4

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 or at the last observation following Baseline is presented.

Time frame: Week 4 or last observation following Baseline

Population: Full analysis set defined as subjects who have at least one observation after Baseline

The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.

Time frame: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 1.

Time frame: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 1.

Time frame: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.

Time frame: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 2.

Time frame: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 2.

Time frame: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 2 in the total score.

Time frame: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.

Time frame: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4.

Time frame: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 4.

Time frame: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 in the total score.

Time frame: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Endpoint.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.

The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline in the total score.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.

The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.

Time frame: Baseline and 4 weeks (or last observation after Baseline)

Population: Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.