SchizophreniafMRINCT00431223
Brain Activation Patterns in Schizophrenia After Computerized Cognitive Skills Training
A study testing Cognitive remediation therapy in people with Schizophrenia, run by Manhattan Psychiatric Center at 1 site in United States.
Trial summary
This project is a novel exploratory research project to investigate changes in activation patterns of the dorsolateral prefrontal cortex (DLPFC) in inpatients with schizophrenia who received a 12-week computerized cognitive remediation (CRT) program. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cognitive remediation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2008
- 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Inpatient status
- Age 18 - 55
- Male gender (females are enrolled but will not be scanned)
- DSM-IV diagnosis of schizophrenia (all subtypes) and schizoaffective disorder
- illness duration > 5 years
- MMSE score > 24 (inclusive) at screening
Show all 10Show fewer
- Stable dose of oral atypical antipsychotic for at least 4 weeks prior to study entry
- Total PANSS score > 60 at screening
- Capacity and willingness to give written informed consent
- Patients deemed not ready to be discharged within the next 12 weeks
Who cannot join
- Inability to read or speak English
- Documented disease of the central nervous system
- History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation)
- Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary, or hematological conditions; HIV positive
- Any medical condition rendering the subject unable to receive an fMRI scan
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Psychiatric Center
New York, New York, 10035
About this study
Official title: Does Computerized Cognitive Skills Training Change Brain Activation Patterns in Schizophrenia?
This project is a novel exploratory research project to investigate changes in activation patterns of the dorsolateral prefrontal cortex (DLPFC) in inpatients with schizophrenia who received a 12-week computerized cognitive remediation (CRT) program. The hypothesis is that patients receiving CRT will show greater increase in activation patterns in the brain as compared to controls, and the degree of brain activation will correlate with improvements in working memory.
Read the detailed description
Abnormalities in the domains of attention, working memory (WM) and information processing are important features of schizophrenia. There is growing literature that cognitive remediation therapy (CRT) can produce modest improvements in cognitive functioning in schizophrenia, suggesting that systematic efforts at improving cognitive functioning are feasible. Cognitive improvement after CRT may correlate with changes in brain activation patterns in specific areas.
After screening, patients are randomized to a 12 week trial of CRT using COGPACK (Marker Software), or to a 12-week control condition. All patients attend 3 weekly 1-hour laboratory sessions, with 1 discussion session per week.
Patients continue their antipsychotic treatment with a typical or atypical antipsychotic during the CRT and 4 weeks prior to enrollment in the study (Phase A). Following Phase A they receive baseline evaluations, including an cognitive activation task (N-back visual-letter task) while being scanned for fMRI , MATRICS neuropsychological test battery, and psychiatric, social functioning, and symptoms assessment.
Patients then enter Phase B with randomization to control or CRT for 12 weeks (36 laboratory sessions). Upon successful completion of 36 sessions, endpoint evaluations include an N-back task while fMRI scan, MATRICS, psychiatric, and social functional assessments.
All baseline and endpoint fMRI scans are conducted at the Center for Advanced Brain Imaging (CABI) at Nathan Kline Institute for Psychiatric Research.
- Conditions
- Schizophrenia
- Being tested
- Cognitive remediation therapy
- Keywords
- fMRI, working memory, schizophrenia, treatment refractory, cognitive skills training, dorsolateral prefrontal cortex, cognitive remediation, treatment refractory schizophrenia of > 5 years duration
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediation therapyBehavioural
Also called CRT Group
36 sessions of computerized cognitive skills training over a 12 week duration. 7 patients were assigned to cognitive remediation therapy or CRT Group.
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Active comparator | 7 patients were assigned to Cognitive Remediation Therapy.. Receives: Behavioral: Cognitive remediation therapy |
| Control Group | No intervention | 4 patients were assigned to Control group or no cognitive remediation therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activation changes after stimulation with a neurocognitive task in the dorso-lateral prefrontal cortex (DLPFC)
Measured: 12 weeks
Secondary outcomes (1)
Examine the relationship of changes in DLPFC activation patterns in relation to improvement on neurocognitive tests
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manhattan Psychiatric Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research
- Responsible party
- Principal investigator, Jean-Pierre Lindenmayer, Manhattan Psychiatric Center
- Investigators
- Saurabh Kaushik, MD, Principal investigator, Manhattan Psychaitric CenterJean-Pierre Lindenmayer, MD, Study chair, Manhattan Psychiatric CenterSusan McGurk, PhD, Study chair, Dartmouth College, HanoverCraig A. Branch, PhD, Study chair, Center for Advanced Brain Imaging, NKI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431223
- Sponsor's protocol ID
- 05I/C52
- Acronym
- fMRI
- Status last verified
- Oct 2020
- First submitted
- 2 Feb 2007
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wykes T, Reeder C, Corner J, Williams C, Everitt B. The effects of neurocognitive remediation on executive processing in patients with schizophrenia. Schizophr Bull. 1999;25(2):291-307. doi: 10.1093/oxfordjournals.schbul.a033379.
PubMed 10416732
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Computerized Cognitive Skills Training Change Brain Activation Patterns in Schizophrenia?
- ClinicalTrials.gov ID
- NCT00431223
- Acronym / sponsor ID
- fMRI / 05I/C52
- Conditions
- Schizophrenia
- Keywords
- fMRI, working memory, schizophrenia, treatment refractory, cognitive skills training, dorsolateral prefrontal cortex, cognitive remediation, treatment refractory schizophrenia of > 5 years duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Manhattan Psychiatric CenterUniversity, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 5 Feb 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.
This project is a novel exploratory research project to investigate changes in activation patterns of the dorsolateral prefrontal cortex (DLPFC) in inpatients with schizophrenia who received a 12-week computerized cognitive remediation (CRT) program. The hypothesis is that patients receiving CRT will show greater increase in activation patterns in the brain as compared to controls, and the degree of brain activation will correlate with improvements in working memory.
Detailed description
Abnormalities in the domains of attention, working memory (WM) and information processing are important features of schizophrenia. There is growing literature that cognitive remediation therapy (CRT) can produce modest improvements in cognitive functioning in schizophrenia, suggesting that systematic efforts at improving cognitive functioning are feasible. Cognitive improvement after CRT may correlate with changes in brain activation patterns in specific areas.
After screening, patients are randomized to a 12 week trial of CRT using COGPACK (Marker Software), or to a 12-week control condition. All patients attend 3 weekly 1-hour laboratory sessions, with 1 discussion session per week.
Patients continue their antipsychotic treatment with a typical or atypical antipsychotic during the CRT and 4 weeks prior to enrollment in the study (Phase A). Following Phase A they receive baseline evaluations, including an cognitive activation task (N-back visual-letter task) while being scanned for fMRI , MATRICS neuropsychological test battery, and psychiatric, social functioning, and symptoms assessment.
Patients then enter Phase B with randomization to control or CRT for 12 weeks (36 laboratory sessions). Upon successful completion of 36 sessions, endpoint evaluations include an N-back task while fMRI scan, MATRICS, psychiatric, and social functional assessments.
All baseline and endpoint fMRI scans are conducted at the Center for Advanced Brain Imaging (CABI) at Nathan Kline Institute for Psychiatric Research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Active comparator | Behavioral: Cognitive remediation therapy7 patients were assigned to Cognitive Remediation Therapy.. |
| Control Group | No intervention | –4 patients were assigned to Control group or no cognitive remediation therapy. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Inpatient status
- Age 18 - 55
- Male gender (females are enrolled but will not be scanned)
- DSM-IV diagnosis of schizophrenia (all subtypes) and schizoaffective disorder
- illness duration > 5 years
Key exclusion criteria (5 listed)
- Inability to read or speak English
- Documented disease of the central nervous system
- History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation)
- Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary, or hematological conditions; HIV positive
- Any medical condition rendering the subject unable to receive an fMRI scan
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 |
|---|---|---|
| Cognitive remediation therapyAlso: CRT Group36 sessions of computerized cognitive skills training over a 12 week duration. 7 patients were assigned to cognitive remediation therapy or CRT Group. | Behavioural | Active Group |
Primary outcome
Brain activation changes after stimulation with a neurocognitive task in the dorso-lateral prefrontal cortex (DLPFC)
Time frame: 12 weeks
1 secondary outcome
Examine the relationship of changes in DLPFC activation patterns in relation to improvement on neurocognitive tests
Time frame: 12 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 6 Oct 2020.
- Background: PubMed 10416732Wykes T, Reeder C, Corner J, Williams C, Everitt B. The effects of neurocognitive remediation on executive processing in patients with schizophrenia. Schizophr Bull. 1999;25(2):291-307. doi: 10.1093/oxfordjournals.schbul.a033379.
- FMRIB Software LibraryLink provided by the sponsor.
- Wikipedia entry for fMRILink provided by the sponsor.
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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.
Saurabh Kaushik, MD principal investigator
Manhattan Psychaitric Center
Jean-Pierre Lindenmayer, MD study chair
Manhattan Psychiatric Center
Susan McGurk, PhD study chair
Dartmouth College, Hanover
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation therapy in people with Schizophrenia, run by Manhattan Psychiatric Center 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 10 inclusion and 5 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 6 Oct 2020. 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?
Brain activation changes after stimulation with a neurocognitive task in the dorso-lateral prefrontal cortex (DLPFC) (time frame: 12 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 NCT00431223, which also lists 1 linked publication.
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 6 Oct 2020.