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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Stephen R. Marder, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01173874
First received: July 8, 2010
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

The investigators hypothesize that cognitive remediation will be superior to the active control group on the change from baseline to study end point of cognitive remediation phase on both co-primary outcome measures (standardized composite MATRICS score and Cognitive Assessment Interview).


Condition Intervention Phase
Schizophrenia
Drug: Cognitive Remediation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Biomarker Assessment of Efficacy of Cognitive Remediation in Patients With Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Cognitive Function/Assessment [ Time Frame: 4-6 month period ] [ Designated as safety issue: No ]

    The NIMH MATRICS Neuropsychological Battery will be used to assess cognitive function. The NIMH MATRICS Neuropsychological Battery is comprised of measures of: a) working memory; b) attention/vigilance; c) verbal memory; d) visual memory; e) processing speed; f) problem solving; and g) social cognition. The MATRICS battery takes 90 minutes or less to complete.

    Co-primary outcome measure is the Cognitive Assessment Interview (CAI). The CAI is a rating scale designed to elicit information from the subject and informant on the level of cognitive related function of the subject.



Secondary Outcome Measures:
  • Functional Levels [ Time Frame: 4-6 month period ] [ Designated as safety issue: No ]
    The key secondary outcome measures are functional level as assessed by the UCSD Performance-Based Skills Assessment (UPSA-Brief), efficacy (change in PANSS score), Side Effect Checklist, AIMS, SAS, BAS, study completion rates, and frequency of abnormal laboratory values.


Estimated Enrollment: 140
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
No Intervention: Cognitive activity control group
This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female between 18-55 years of age who meet DSM-IV-TR criteria for schizophrenia or schizoaffective disorder confirmed by the Structured Clinical Interview for DSM-IV Clinical trial version (SCID-CT version). Duration of illness > 1 year. Outpatient status.
  • Change in antipsychotic medication is clinically warranted as evidenced by

    • persistent psychosis despite adequate dose and duration of antipsychotic, or * inability to achieve therapeutic dose because of dose-limiting side effects,
    • persistent side effects that either cause significant subjective distress or significantly increase medical risks, such as substantial weight gain or metabolic disturbances, or
    • patient preference to switch and treating psychiatrist is in agreement.
  • No behaviors suggesting potential danger to self or others over the 6 months prior to participation.
  • For the last 2 weeks of lurasidone stabilization phase, a score of 4 or less on PANSS items of conceptual disorganization, hallucinations, suspiciousness and unusual thought content items.
  • At end of lurasidone stabilization phase, Simpson-Angus Scale total score <
  • At end of lurasidone stabilization phase, Calgary Depression Scale total score <10.
  • No acute medical problems; any chronic medical condition (e.g. hypertension) consistently treated and stable during the 1 month prior to participation.
  • Able to provide signed informed consent and to cooperate with all study procedures.
  • Able to attend twice weekly sessions (each lasting approximately 75 minutes) for cognitive remediation or active control sessions for the ~6 month duration of the cognitive remediation phase of the study.
  • Must meet the following cognitive performance criteria:

    • Able to complete the baseline MATRICS validly at baseline as assessed by NP tester.
    • Raw score of 12 or greater on the WTAR (Wechsler Test of Adult Reading) at screening.
  • Women who can become pregnant must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. Acceptable methods include oral, injectable or implanted contraceptives, intrauterine devices or barrier methods such as condoms, diaphragm and spermicides. Women who can become pregnant must have a negative urine pregnancy test at the Screening Visit. Women who can become pregnant include anyone who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), or is not postmenopausal (defined as amenorrhea 12 consecutive months).

Exclusion Criteria:

  • Documented history of learning disability.
  • Hearing or visual impairment; not fluent in English.
  • Current treatment with clozapine or history of treatment resistance as evidenced by failure to improve (in the judgment of the investigator) with 2 or more adequate dose antipsychotic trials of at least 6 weeks duration in preceding 1 year.
  • Concomitant or anticipated treatment with potent CYP 3A4 inhibitor such a cimetidine, cyclosporine, erythromycin or erythromycin-like drugs (e.g., azithromycin, clarithromycin except short term acute treatment for 1 week or less), diltiazem, itraconazole, ketoconazole or other systemic antifungal agents in the azole class, nefazodone; or potent CYP3A4 inducer including: carbamazepine, modafinil, Phenobarbital, phenytoin, rifampin, St. Johns Wort, and troglitazone.
  • Current treatment with psychotropic agents known to affect cognition such as amphetamines, topiramate.
  • History of treatment with electroconvulsive therapy within the 6 months prior to participation or expectation that patient may require ECT during the study.
  • History of neurological or neuropsychiatric conditions (e.g. stroke, traumatic brain injury, epilepsy, etc).
  • Subjects with a history of clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorders (e.g. unstable angina, decompensate congestive heart failure, CNS infection or history of HIV seropositivity), which would pose a risk to the patient if they were to participate in the study or that might confound the results of the study. Active medical conditions that are minor or well controlled are not exclusionary if they do not affect risk to the patient of the study results. For example, the following are not exclusionary: a) stable and well-controlled hypertension; b) asthma (no serious attacks in the past year); c) hypothyroidism (TSH within normal limits).
  • A positive test for Hepatitis C antibody with concurrent evidence of impaired hepatic function (increased AST or ALT greater than 2 times the upper limit of normal) or positive tests for Hepatitis A antibody IgM fraction or Hepatitis B surface antigen, irrespective of the AST or ALT values.
  • History of alcohol or substance abuse or dependence during the 6 months prior to participation.
  • Participation in a clinical trial involving an investigational medication within 3 months prior to participation or 2 or more investigational drug trials in the preceding 12 months.
  • Pregnant women or women of child-bearing potential who are not using adequate birth control.
  • Woman who are breast feeding.
  • Individuals who: a) received any cognitive remediation in the 6 months prior to study entry or b)received more than 6 hours of cognitive remediation in the 12 months prior to study entry or c) received more than 15 hours in the 24 months prior to study entry. Cognitive remediation is defined as any behavioral intervention consisting of training activities that aim to target impairments in cognitive domains of sensory processing, attention, memory, processing speed, working memory, and executive functioning.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173874

Contacts
Contact: Marlene M. Carlson 212-543-5678 mcarlson@pi.cpmc.columbia.edu

Locations
United States, California
San Fernando Mental Health Center Recruiting
Granada Hills, California, United States, 91344
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Alex Kopelowicz, M.D.         
University of California - Irvine Recruiting
Orange, California, United States, 92868
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Steve Potkin, M.D.         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Deepak C. D'Souza,, M.D.         
United States, Florida
University of Miami Department of Psychiatry Recruiting
Miami, Florida, United States, 33136
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Richard Steinbook, M.D.         
United States, Georgia
Medical College of Georgia Not yet recruiting
Augusta, Georgia, United States, 30912
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Peter Buckley, M.D.         
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Will Cronenwett, M.D.         
Rush University Psychiatric Clinical Research Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Philip Janicak, M.D.         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46222
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Alan Breier, M.D.         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Matcheri Keshavan, M.D.         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Stephen Olsen, M.D.         
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: John Lauriello, M.D.         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Fred Jarskog, M.D.         
Psychopharmacology Research Unit- Nathan KIine Institute for Psychiatric Research Recruiting
New York, New York, United States, 10035
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: J.P. Lindenmayer, M.D.         
United States, North Carolina
Duke University Medical Center Recruiting
Butner, North Carolina, United States, 27509
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Joseph McEvoy, M.D.         
Principal Investigator: Ashwin Patkar, M.D.         
United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Matthew Byerly, M.D.         
University of Texas Health Science Center, San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Marlene Carlson    212-543-5678      
Principal Investigator: Dawn Velligan         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Jeffrey Lieberman, M.D. Columbia University
Principal Investigator: Zafar Sharif, M.D. Columbia University
  More Information

Publications:
Westfall PH. 1997. Multiple testing of general contrasts using logical constraints and correlations, J Am Stat Assoc, 92; 299-306.
Cohen JD, Forman SD, Braver TS, Casey BJ, Servan-Schreiber D, Noll DC: Activation of prefrontal cortex in a nonspatial working memory task with functional MRI. Human Brain Mapping; 1: 293-304, 1994.
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: Stephen R. Marder, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01173874     History of Changes
Other Study ID Numbers: TENETS01
Study First Received: July 8, 2010
Last Updated: October 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
Cognition
Function
Attention
Vigilance
Verbal Memory
Visual Memory
Processing Speed
Problem Solving
Social Cognition

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 23, 2014