NCT00499044

Brief Summary

The investigators will compare the test-retest reliabilities of two cognitive batteries in people with schizophrenia: Cognitive Drug Research Computerized Cognitive Assessment System ("CDR") and MATRICS Consensus Cognitive Battery ("MCCB"). The investigators hypothesize that there will be a statistically significant difference in the test-retest reliabilities between MCCB and CDR. In addition, the investigators hypothesize that each of the two batteries will better measure certain areas of cognition. The investigators also hypothesize that scores from both batteries will correlate with quality of life scores, and that there will be a significant difference between the correlations of MCCB and CDR. The investigators hypothesize there will be a significant difference in patients' self-reported tolerability and satisfaction of the MATRICS versus CDR assessments. Lastly, the investigators hypothesize that there will be a significant difference in the MATRICS versus CDR batteries with respect to an administrator-rated score of practicality. Approximately 32 subjects will enroll in the study. Following consent and eligibility screening (visit 1) and baseline clinical assessment and training in the use of the CDR battery (visit 2), subjects will be randomized into one of two groups for visits 3 and 4. One group will complete the CDR and then MCCB in visit 3, as well as the Tolerability Scale for each battery. The other group will complete the batteries in reverse order during visit 3. Each group will complete both batteries again in reverse order for visit 4. Randomization will be done in blocks of 2. After completion of every 4 subjects, study administrators will complete the Practicality Scale for each battery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Dec 2007

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 26, 2009

Status Verified

November 1, 2009

Enrollment Period

1.2 years

First QC Date

July 9, 2007

Last Update Submit

November 25, 2009

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

cognitionattentionmemoryconcentrationschizophrenia

Outcome Measures

Primary Outcomes (1)

  • Test-retest reliabilities of MATRICS Consensus Cognitive Battery (MCCB) and the Cognitive Drug Research (CDR) Computerized Cognitive Assessment System

    4 weeks

Secondary Outcomes (4)

  • Cognitive domains measured by MCCB versus CDR

    4 weeks

  • Correlation of MCCB versus CDR scores with clinical measures of quality of life

    4 weeks

  • Self-reported tolerability and satisfaction of the MCCB and CDR assessments

    4 weeks

  • Practicality of MCCB versus CDR as reported by test administrators

    4 weeks

Study Arms (2)

1

EXPERIMENTAL

MATRICS Consensus Cognitive Battery

Other: MATRICS Consensus Cognitive Battery

2

EXPERIMENTAL

Cognitive Drug Research Computerized Cognitive Assessment System

Other: CDR Computerized Cognitive Assessment System

Interventions

CDR Computerized Cognitive Assessment SystemOTHER

Cognitive Drug Research Computerized Cognitive Assessment System consists of performance tasks that measure reaction time, numeric and spatial working memory, word and picture recall and recognition, and episodic secondary memory. CDR is a single, unified battery that can be stored and administered using a laptop computer.

Also known as: CDR
2
MATRICS Consensus Cognitive BatteryOTHER

The MATRICS Consensus Cognitive Battery measures functioning across various cognitive domains, such as attention, working memory (verbal and nonverbal), learning (verbal and visual), reasoning and problem solving, and social cognition. Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes.

Also known as: MCCB, MATRICS
1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women and men aged 18-65 with DSM-IV diagnosis of schizophrenia or schizoaffective disorder (depressed type) by diagnostic interview and chart review.
  • Clinically stable on a stable dose of antipsychotic medication for at least one month; no current active suicidal ideation.
  • Not treated with investigational medication in the past 30 days.
  • Competent to provide informed consent.

You may not qualify if:

  • Diagnosis of dementia, neurodegenerative disease, seizure disorder, current substance abuse or dependence disorders, including alcohol, active within the last 3 months or any Axis I DSM-IV diagnosis other than schizophrenia or schizoaffective disorder (depressed type).
  • Serious illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease that is not stabilized such that hospitalization for treatment of that illness is likely within the next two months.
  • Patients who, in the investigator's opinion, pose a current severe homicide or suicide risk.
  • History of multiple head injuries with neurological sequelae or a single severe head injury with lasting neurological sequelae.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freedom Trail Clinic, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

  • Green MF, Kern RS, Heaton RK. Longitudinal studies of cognition and functional outcome in schizophrenia: implications for MATRICS. Schizophr Res. 2004 Dec 15;72(1):41-51. doi: 10.1016/j.schres.2004.09.009.

    PMID: 15531406BACKGROUND

  • Andreasen NC. The Scale for the Assessment of Negative Symptoms (SANS): conceptual and theoretical foundations. Br J Psychiatry Suppl. 1989 Nov;(7):49-58. No abstract available.

    PMID: 2695141BACKGROUND

  • Heinrichs DW, Hanlon TE, Carpenter WT Jr. The Quality of Life Scale: an instrument for rating the schizophrenic deficit syndrome. Schizophr Bull. 1984;10(3):388-98. doi: 10.1093/schbul/10.3.388.

    PMID: 6474101BACKGROUND

  • Cornblatt BA, Risch NJ, Faris G, Friedman D, Erlenmeyer-Kimling L. The Continuous Performance Test, identical pairs version (CPT-IP): I. New findings about sustained attention in normal families. Psychiatry Res. 1988 Nov;26(2):223-38. doi: 10.1016/0165-1781(88)90076-5.

    PMID: 3237915BACKGROUND

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • A. Eden Evins, M.D., M.P.H.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 11, 2007

Study Start

December 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 26, 2009

Record last verified: 2009-11

Locations

US(1)