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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01173874
First received: July 8, 2010
Last updated: February 28, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: 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 New York State Psychiatric Institute:

Primary Outcome Measures:
  • Cognitive Function Measured by MCCB Composite Score [ Time Frame: 4-6 month period ]

    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.


  • 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 ]
    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.


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

    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

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

    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


Enrollment: 120
Study Start Date: July 2010
Study Completion Date: November 2013
Primary Completion Date: October 2013 (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   (Adult)
Sexes Eligible for Study:   All
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

Locations
United States, California
San Fernando Mental Health Center
Granada Hills, California, United States, 91344
University of California - Irvine
Orange, California, United States, 92868
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
United States, Florida
University of Miami Department of Psychiatry
Miami, Florida, United States, 33136
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Psychiatric Clinical Research Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46222
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
United States, New York
Columbia University
New York, New York, United States, 10032
Psychopharmacology Research Unit- Nathan KIine Institute for Psychiatric Research
New York, New York, United States, 10035
United States, North Carolina
Duke University Medical Center
Butner, North Carolina, United States, 27509
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
University of Texas Health Science Center, San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
New York State Psychiatric Institute
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.
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
Study First Received: July 8, 2010
Results First Received: November 1, 2016
Last Updated: February 28, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by New York State Psychiatric Institute:
Cognition
Function
Attention
Vigilance
Verbal Memory
Visual Memory
Processing Speed
Problem Solving
Social Cognition

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 26, 2017