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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Cognitive Remediation   Cognitive Activity Control Group
STARTED   56   64 
COMPLETED   33   41 
NOT COMPLETED   23   23 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Cognitive Remediation   Cognitive Activity Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   64   120 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.1  (9.9)   38.1  (10.3)   37.7  (10.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      22  39.3%      20  31.3%      42  35.0% 
Male      34  60.7%      44  68.8%      78  65.0% 


  Outcome Measures

1.  Primary:   Cognitive Function Measured by MCCB Composite Score   [ Time Frame: 4-6 month period ]

2.  Primary:   Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale   [ Time Frame: 4-6 month period ]

3.  Secondary:   Cognition as Measured by Cognitive Assessment Interview (CAI)   [ Time Frame: 4-6 month period ]

4.  Secondary:   Efficacy as Measured by Positive and Negative Syndrome Scale (PANSS)   [ Time Frame: 4-6 month period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: mcarlson@nyspi.columbia.edu


Publications of Results:
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