Trial Outcomes & Findings for Efficacy of Cognitive Remediation in Patients With Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone (NCT NCT01173874)

Results Overview

The MATRICS Consensus Cognitive Battery (MCCB) will be used to assess cognitive function. The MCCB composite score is comprised of sub-scale measures of: a) working memory; b) attention and vigilance; c) verbal learning; d) visual learning; e) speed of processing; f) reason and problem solving; and g) social cognition. The MCCB takes 90 minutes or less to complete. MCCB assessed 4 times: prestabilization (screening), randomization (after 6-8 weeks of lurasidone stabilization, prior to initial cognitive remediation), midpoint (after 20 cognitive remediation session), and study completion (final visit after 30 cognitive remediation sessions). MCCB composite scores are reported as t-scores where a t-score = 50 is the population average. Every 10 points is one standard deviation. There is no range as scores are as far from population average.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

120 participants

Primary outcome timeframe

4-6 month period

Results posted on

2017-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Cognitive Remediation Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving. Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.	Cognitive Activity Control Group This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
Overall Study STARTED	56	64
Overall Study COMPLETED	33	41
Overall Study NOT COMPLETED	23	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Cognitive Remediation in Patients With Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Remediation n=56 Participants Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving. Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.	Cognitive Activity Control Group n=64 Participants This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.	Total n=120 Participants Total of all reporting groups
Age, Continuous	37.1 years STANDARD_DEVIATION 9.9 • n=5 Participants	38.1 years STANDARD_DEVIATION 10.3 • n=7 Participants	37.7 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	44 Participants n=7 Participants	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4-6 month period

Population: Completers

The MATRICS Consensus Cognitive Battery (MCCB) will be used to assess cognitive function. The MCCB composite score is comprised of sub-scale measures of: a) working memory; b) attention and vigilance; c) verbal learning; d) visual learning; e) speed of processing; f) reason and problem solving; and g) social cognition. The MCCB takes 90 minutes or less to complete. MCCB assessed 4 times: prestabilization (screening), randomization (after 6-8 weeks of lurasidone stabilization, prior to initial cognitive remediation), midpoint (after 20 cognitive remediation session), and study completion (final visit after 30 cognitive remediation sessions). MCCB composite scores are reported as t-scores where a t-score = 50 is the population average. Every 10 points is one standard deviation. There is no range as scores are as far from population average.

Outcome measures

Outcome measures
Measure	Cognitive Remediation n=33 Participants Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving. Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.	Cognitive Activity Control Group n=41 Participants This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
Cognitive Function Measured by MCCB Composite Score	35.39 units on a scale Standard Deviation 11.99	30.73 units on a scale Standard Deviation 14.97

PRIMARY outcome

Timeframe: 4-6 month period

Population: Completed subjects

The UPSA-B assesses functional capacity to perform tasks similar to those in daily life. Raw scores are converted into scaled scores ranging from 0-100, with higher scores indicating better functional capacity.

Outcome measures

Outcome measures
Measure	Cognitive Remediation n=33 Participants Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving. Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.	Cognitive Activity Control Group n=40 Participants This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale	79.74 units on a scale Standard Deviation 10.99	75.85 units on a scale Standard Deviation 16.37

SECONDARY outcome

Timeframe: 4-6 month period

Population: completed subjects with available completed CAI data. Numbers above are correct as not all completed subjects (Analysis Population Description) had completed CAI assessment available for analysis.

Cognitive Assessment Interview was used to obtain information about cognitive functioning from both subject and an informant. Composite CAI scores were reported. Scale ranges from 1-7 with the following anchors: 1. Normal, no cognitive impairment 2. Borderline impairment 3. Mildly impaired 4. Moderately impaired 5. Markedly impaired 6. Severely impaired 7. Among the most extremely impaired

Outcome measures

Outcome measures
Measure	Cognitive Remediation n=31 Participants Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving. Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.	Cognitive Activity Control Group n=40 Participants This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
Cognition as Measured by Cognitive Assessment Interview (CAI)	2.74 units on a scale Standard Deviation 1.6	2.79 units on a scale Standard Deviation 1.18

SECONDARY outcome

Timeframe: 4-6 month period

Population: Completed subjects

Total PANSS score with 30 items. Each item is rated 1-7 so the minimum Total PANSS score =30 and the maximum is 210. Anchors for each item are as follows, the higher values represent an increase in severity of symptoms: 1. Absent 2. Minimal 3. Mild 4. Moderate 5. Moderately severe 6. Severe 7. Extremely severe

Outcome measures

Outcome measures
Measure	Cognitive Remediation n=33 Participants Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving. Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.	Cognitive Activity Control Group n=41 Participants This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
Efficacy as Measured by Positive and Negative Syndrome Scale (PANSS)	58.79 units on a scale Standard Deviation 14.71	61.1 units on a scale Standard Deviation 17.29

Adverse Events

Cognitive Remediation

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive Activity Control Group

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cognitive Remediation n=56 participants at risk Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving. Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.	Cognitive Activity Control Group n=64 participants at risk This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
Nervous system disorders Exacerbation	7.1% 4/56 • Number of events 5	9.4% 6/64 • Number of events 7
Cardiac disorders abnormal ECG	1.8% 1/56 • Number of events 1	1.6% 1/64 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joshua Kantrowitz

New York State Psychiatric Institute

Phone: 646-774-8436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place