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

NCT01173874 | Completed Phase 3 Results DMC

• 1 other identifier: #6121
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 16

Brief Summary

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).

Conditions

Schizophrenia

Keywords

Cognition; Function; Attention; Vigilance; Verbal Memory; Visual Memory; Processing Speed; Problem Solving; Social Cognition

Outcome Measures

Primary Outcomes (2)

• Cognitive Function Measured by MCCB Composite Score

  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.

  4-6 month period

• Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale

  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.

  4-6 month period

Secondary Outcomes (2)

• Cognition as Measured by Cognitive Assessment Interview (CAI)

  4-6 month period

• Efficacy as Measured by Positive and Negative Syndrome Scale (PANSS)

  4-6 month period

Study Arms (2)

Cognitive Remediation

EXPERIMENTAL

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 activity control group

NO INTERVENTION

This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.

Interventions

Cognitive Remediation DRUG

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (16)

San Fernando Mental Health Center

Granada Hills, California, 91344, United States

Location

University of California - Irvine

Orange, California, 92868, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

University of Miami Department of Psychiatry

Miami, Florida, 33136, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Psychiatric Clinical Research Center

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46222, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Psychopharmacology Research Unit- Nathan KIine Institute for Psychiatric Research

New York, New York, 10035, United States

Location

Duke University Medical Center

Butner, North Carolina, 27509, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

University of Texas Health Science Center, San Antonio

San Antonio, Texas, 78229, United States

Location

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MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Joshua Kantrowitz
• Organization: New York State Psychiatric Institute

mcarlson@nyspi.columbia.edu

646-774-8436

Study Officials

• Jeffrey Lieberman, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

• Zafar Sharif, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: August 2, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)