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Trial record 1 of 1 for:    2069492 [PUBMED-IDS]
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Efficacy of Cognitive Remediation in Patients With Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone

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ClinicalTrials.gov Identifier: NCT01173874
Recruitment Status : Completed
First Posted : August 2, 2010
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Cognitive Remediation
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive Remediation Cognitive Activity Control Group
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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.

This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
Period Title: Overall Study
Started 56 64
Completed 33 41
Not Completed 23 23
Arm/Group Title Cognitive Remediation Cognitive Activity Control Group Total
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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.

This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions. Total of all reporting groups
Overall Number of Baseline Participants 56 64 120
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Randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 64 participants 120 participants
37.1  (9.9) 38.1  (10.3) 37.7  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 64 participants 120 participants
Female
22
  39.3%
20
  31.3%
42
  35.0%
Male
34
  60.7%
44
  68.8%
78
  65.0%
1.Primary Outcome
Title Cognitive Function Measured by MCCB Composite Score
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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.

Time Frame 4-6 month period
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Completers
Arm/Group Title Cognitive Remediation Cognitive Activity Control Group
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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.

This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
Overall Number of Participants Analyzed 33 41
Mean (Standard Deviation)
Unit of Measure: units on a scale
35.39  (11.99) 30.73  (14.97)
2.Primary Outcome
Title Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale
Hide Description 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.
Time Frame 4-6 month period
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Completed subjects
Arm/Group Title Cognitive Remediation Cognitive Activity Control Group
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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.

This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
Overall Number of Participants Analyzed 33 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
79.74  (10.99) 75.85  (16.37)
3.Secondary Outcome
Title Cognition as Measured by Cognitive Assessment Interview (CAI)
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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
Time Frame 4-6 month period
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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.
Arm/Group Title Cognitive Remediation Cognitive Activity Control Group
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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.

This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
Overall Number of Participants Analyzed 31 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.74  (1.6) 2.79  (1.18)
4.Secondary Outcome
Title Efficacy as Measured by Positive and Negative Syndrome Scale (PANSS)
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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
Time Frame 4-6 month period
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Completed subjects
Arm/Group Title Cognitive Remediation Cognitive Activity Control Group
Hide Arm/Group Description:

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.

This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
Overall Number of Participants Analyzed 33 41
Mean (Standard Deviation)
Unit of Measure: units on a scale
58.79  (14.71) 61.1  (17.29)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Remediation Cognitive Activity Control Group
Hide Arm/Group Description

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.

This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
All-Cause Mortality
Cognitive Remediation Cognitive Activity Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Remediation Cognitive Activity Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/56 (8.93%)      7/64 (10.94%)    
Cardiac disorders     
abnormal ECG  1/56 (1.79%)  1 1/64 (1.56%)  1
Nervous system disorders     
Exacerbation  4/56 (7.14%)  5 6/64 (9.38%)  7
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cognitive Remediation Cognitive Activity Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/56 (0.00%)      0/64 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Joshua Kantrowitz
Organization: New York State Psychiatric Institute
Phone: 646-774-8436
Other Publications:
Westfall PH. 1997. Multiple testing of general contrasts using logical constraints and correlations, J Am Stat Assoc, 92; 299-306.
Westfall PH, Tobias RD, Rom D, Wolfinger RD, Hochberg Y. Multiple comparisons and multiple tests using the SAS7 system, SAS Institute, Inc., Cary NC, pp. 149-175, 335-343, 1999.
Schafer, JL. Analysis of Incomplete Multivariate Data, New York: Chapman and Hall. 1997
Little RJA, and Rubin DB. Statistical Analysis with Missing Data, Second Edition, New York: John Wiley & Sons, Inc. 2002.
Holm S. A simple sequentially rejective multiple test procedure. Scandinavian Journal of Statistics, 6, 65-70, 1979.
Kayser, J., Tenke, C.E. Consensus on PCA for ERP data, and sensibility of unrestricted solutions. Clinical Neurophysiology, 117(3), 703-707. (2006c).
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01173874     History of Changes
Other Study ID Numbers: #6121
First Submitted: July 8, 2010
First Posted: August 2, 2010
Results First Submitted: November 1, 2016
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017