SchizophreniaNCT00499044
A Comparison of Two Cognitive Batteries in People With Schizophrenia
A study testing CDR Computerized Cognitive Assessment System and MATRICS Consensus Cognitive Battery in people with Schizophrenia and Schizoaffective Disorder, run by North Suffolk Mental Health Association at 1 site in United States.
Trial 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"). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- CDR Computerized Cognitive Assessment System and MATRICS Consensus Cognitive Battery
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Freedom Trail Clinic, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: CDR Versus MATRICS Cognitive Batteries in Patients With Schizophrenia
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.
Read the detailed description
The National Institute of Mental Health's Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) program was a collaboration between members of academia, industry, and the government, with the goal of furthering the development of drugs for the treatment of the cognitive deficits of schizophrenia. The program led to the creation of the MATRICS Consensus Cognitive Battery (MCCB), which 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.
Cognitive Drug Research (CDR) is a United Kingdom-based company that has developed another battery of assessments capable of measuring cognitive function in patients with schizophrenia. Its 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.
Cognitive assessments are important in establishing the efficacy of medications and other therapeutic interventions for improving cognitive function in patients with schizophrenia. Furthermore, this cognitive functioning is correlated with patients' ability to operate in the real world. This study aims to examine the test-retest reliabilities of the CDR and MATRICS cognitive batteries, and thereby gauge their value for use in studies of cognitive functioning in people with schizophrenia. The investigators hypothesize that for patients with schizophrenia there will be a significant difference in the test-retest reliabilities between the two batteries. Additional aims are to investigate the extent to which MCCB and CDR measure functioning in specific cognitive domains and to investigate patient tolerability and overall practicality of each battery.
Visit 1 (1.5 hours): Baseline Measures and Screening
- Consent
- Review of medical chart to confirm DSM-IV diagnosis of schizophrenia/schizoaffective disorder (depressed type) and medical/psychiatric stability
- Demographic questionnaire
- Salivary drug test to exclude current use of PCP, cannabis, alcohol, cocaine, amphetamine, methamphetamine, and opiates
Visit 2 (2 hours): Clinical Assessment and Training
- Clinical Rating Scales: Scale for the Assessment of Negative Symptoms (SANS), Brief Psychiatric Rating Scale (BPRS), Quality of Life Scale (QLS)
- CDR training
Visits 3 and 4 (2.5 hours each): Patients are randomized into one of two groups:
Group 1
- Visit 3: CDR battery followed by MATRICS battery (with short break in between); Tolerability Scale after each battery.
- Visit 4 (two weeks after Visit 3): MATRICS battery followed by CDR battery (with short break in between); Tolerability Scale after each battery.
Group 2
- Visit 3: MATRICS battery followed by CDR battery (with short break in between); Tolerability Scale after each battery.
- Visit 4 (two weeks after Visit 3): CDR battery followed by MATRICS battery (with short break in between); Tolerability Scale after each battery.
Subjects will undergo a screening visit and chart review to assure the clinical appropriateness and safety of their participation. Subjects are free to withdraw from the study at any stage without giving a reason.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- CDR Computerized Cognitive Assessment System, MATRICS Consensus Cognitive Battery
- Keywords
- cognition, attention, memory, concentration, schizophrenia
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDR Computerized Cognitive Assessment SystemOther
Also called CDR
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.
MATRICS Consensus Cognitive BatteryOther
Also called MCCB, MATRICS
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MATRICS Consensus Cognitive Battery Receives: Other: MATRICS Consensus Cognitive Battery |
| 2 | Experimental | Cognitive Drug Research Computerized Cognitive Assessment System Receives: Other: CDR Computerized Cognitive Assessment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest reliabilities of MATRICS Consensus Cognitive Battery (MCCB) and the Cognitive Drug Research (CDR) Computerized Cognitive Assessment System
Measured: 4 weeks
Secondary outcomes (4)
Cognitive domains measured by MCCB versus CDR
Measured: 4 weeks
Correlation of MCCB versus CDR scores with clinical measures of quality of life
Measured: 4 weeks
Self-reported tolerability and satisfaction of the MCCB and CDR assessments
Measured: 4 weeks
Practicality of MCCB versus CDR as reported by test administrators
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startDec 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Suffolk Mental Health Association
- Sponsor type
- University, hospital or other
- Investigators
- A. Eden Evins, M.D., M.P.H., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499044
- Sponsor's protocol ID
- CORRC #18-2007
- Status last verified
- Nov 2009
- First submitted
- 9 Jul 2007
- Last updated
- 26 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15531406Andreasen 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.
PubMed 2695141Heinrichs 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.
PubMed 6474101Cornblatt 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.
PubMed 3237915
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CDR Versus MATRICS Cognitive Batteries in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00499044
- Acronym / sponsor ID
- CORRC #18-2007
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- cognition, attention, memory, concentration, schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- North Suffolk Mental Health AssociationUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The National Institute of Mental Health's Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) program was a collaboration between members of academia, industry, and the government, with the goal of furthering the development of drugs for the treatment of the cognitive deficits of schizophrenia. The program led to the creation of the MATRICS Consensus Cognitive Battery (MCCB), which 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.
Cognitive Drug Research (CDR) is a United Kingdom-based company that has developed another battery of assessments capable of measuring cognitive function in patients with schizophrenia. Its 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.
Cognitive assessments are important in establishing the efficacy of medications and other therapeutic interventions for improving cognitive function in patients with schizophrenia. Furthermore, this cognitive functioning is correlated with patients' ability to operate in the real world. This study aims to examine the test-retest reliabilities of the CDR and MATRICS cognitive batteries, and thereby gauge their value for use in studies of cognitive functioning in people with schizophrenia. The investigators hypothesize that for patients with schizophrenia there will be a significant difference in the test-retest reliabilities between the two batteries. Additional aims are to investigate the extent to which MCCB and CDR measure functioning in specific cognitive domains and to investigate patient tolerability and overall practicality of each battery.
Visit 1 (1.5 hours): Baseline Measures and Screening
- Consent
- Review of medical chart to confirm DSM-IV diagnosis of schizophrenia/schizoaffective disorder (depressed type) and medical/psychiatric stability
- Demographic questionnaire
- Salivary drug test to exclude current use of PCP, cannabis, alcohol, cocaine, amphetamine, methamphetamine, and opiates
Visit 2 (2 hours): Clinical Assessment and Training
- Clinical Rating Scales: Scale for the Assessment of Negative Symptoms (SANS), Brief Psychiatric Rating Scale (BPRS), Quality of Life Scale (QLS)
- CDR training
Visits 3 and 4 (2.5 hours each): Patients are randomized into one of two groups:
Group 1
- Visit 3: CDR battery followed by MATRICS battery (with short break in between); Tolerability Scale after each battery.
- Visit 4 (two weeks after Visit 3): MATRICS battery followed by CDR battery (with short break in between); Tolerability Scale after each battery.
Group 2
- Visit 3: MATRICS battery followed by CDR battery (with short break in between); Tolerability Scale after each battery.
- Visit 4 (two weeks after Visit 3): CDR battery followed by MATRICS battery (with short break in between); Tolerability Scale after each battery.
Subjects will undergo a screening visit and chart review to assure the clinical appropriateness and safety of their participation. Subjects are free to withdraw from the study at any stage without giving a reason.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: MATRICS Consensus Cognitive BatteryMATRICS Consensus Cognitive Battery |
| 2 | Experimental | Other: CDR Computerized Cognitive Assessment SystemCognitive Drug Research Computerized Cognitive Assessment System |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDR Computerized Cognitive Assessment SystemAlso: CDRCognitive 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. | Other | 2 |
| MATRICS Consensus Cognitive BatteryAlso: MCCB, MATRICSThe 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. | Other | 1 |
Primary outcome
Test-retest reliabilities of MATRICS Consensus Cognitive Battery (MCCB) and the Cognitive Drug Research (CDR) Computerized Cognitive Assessment System
Time frame: 4 weeks
4 secondary outcomes
Cognitive domains measured by MCCB versus CDR
Time frame: 4 weeks
Correlation of MCCB versus CDR scores with clinical measures of quality of life
Time frame: 4 weeks
Self-reported tolerability and satisfaction of the MCCB and CDR assessments
Time frame: 4 weeks
Practicality of MCCB versus CDR as reported by test administrators
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2009.
- Background: PubMed 15531406Green 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.
- Background: PubMed 2695141Andreasen 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.
- Background: PubMed 6474101Heinrichs 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.
- Background: PubMed 3237915Cornblatt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Eden Evins, M.D., M.P.H. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDR Computerized Cognitive Assessment System and MATRICS Consensus Cognitive Battery in people with Schizophrenia and Schizoaffective Disorder, run by North Suffolk Mental Health Association at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-retest reliabilities of MATRICS Consensus Cognitive Battery (MCCB) and the Cognitive Drug Research (CDR) Computerized Cognitive Assessment System (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00499044, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2009.