SchizophreniaNCT00655239
Effectiveness of Neuroadaptive Cognitive Training in Adolescents at Risk for Psychosis
A study testing Neuroadaptive cognitive training and Computer games in people with Schizophrenia, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of intensive computerized cognitive training in preventing the onset of psychotic disorder and improving adaptive functioning in adolescents at high risk of schizophrenia. Read more about this study
- Who is it for?
- Ages 12 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Neuroadaptive cognitive training and Computer games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to May 2016
- 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 12 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Meets criteria from the Structured Interview of Prodromal Syndromes for the diagnosis of a prodromal syndrome
- Good general physical health
- English is first language
- Clinically stable (e.g., outpatient status for at least 8 weeks before study entry;on stable doses of medications for at least 1 month before study entry)
Who cannot join
- Confirmed neurological disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94591
About this study
Official title: Neuroscience-Guided Cognitive Remediation in Adolescents at Risk for Psychosis
This study will evaluate the effectiveness of intensive computerized cognitive training in preventing the onset of psychotic disorder and improving adaptive functioning in adolescents at high risk of schizophrenia.
Read the detailed description
Schizophrenia is a severe mental disorder that is marked by significant disruption in a person's thought and emotional processes, frequently involving psychotic features. Identifying behavioral changes and symptoms that indicate the beginning stages of schizophrenia is important for early intervention and prevention of a full psychotic episode. These initial symptoms, known as the prodromal symptoms of psychosis, may include odd behaviors, increased social withdrawal, difficulty concentrating, inappropriate emotional responses, suspicion of others, and dramatic sleep and appetite changes. Common treatments for adolescents demonstrating prodromal symptoms include forms of psychotherapy, nutritional training, and low doses of medication. As a form of psychotherapy, neuroadaptive cognitive training exercises delivered on a computer may be the most effective means of remediating the thinking difficulties of adolescents who are experiencing prodromal symptoms and are at risk for developing a first psychotic episode. This study will evaluate the effectiveness of intensive computerized neuroadaptive cognitive training exercises in preventing the onset of psychotic disorder and improving adaptive functioning in adolescents at high risk of schizophrenia.
Participation in this study will last 24 months and will involve both healthy participants and participants at high risk of schizophrenia. Healthy participants will only participate for 12 months. All participants will undergo baseline assessments that will include an interview, written tests, blood draws, and electroencephalogram (EEG) and magnetic resonance imaging (MRI) scans. Participants at high risk of schizophrenia will then be assigned randomly to receive treatment with either computerized neuroadaptive cognitive training or commercially available computer games. Healthy participants will receive treatment with computerized neuroadaptive cognitive training only. All participants will be asked to complete 60-minute sessions of their assigned treatments 5 days per week for 8 weeks. For participants receiving cognitive training, exercises will focus on improving speed and accuracy in the perception of and response to verbal and visuospatial targets. The treatment will focus on targeted cognitive training (TCT). Participants assigned to practice computer games will play standard, commercially available games, with no targeted response.
Participants will repeat baseline assessments at post treatment and Month 6 of follow-up. The EEG and MRI will be repeated only at the Week 8 assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, healthy controls will be complete, and the at risk participants will continue to be followed up out to 24 months.
- Conditions
- Schizophrenia
- Being tested
- Neuroadaptive cognitive training, Computer games
- Keywords
- Ultra High Risk of Schizophrenia, Prodrome, Psychosis, Schizophrenia, Cognitive Remediation
- 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.
Neuroadaptive cognitive trainingBehavioural
Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.
Computer gamesBehavioural
The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants will use commercially available computer games. Receives: Behavioral: Computer games |
| Active | Experimental | Participants will receive targeted neuroadaptive cognitive training with neuroplasticity-based software created by Posit Science Corporation. Receives: Behavioral: Neuroadaptive cognitive training |
| Healthy Control | Active comparator | Healthy participants will receive targeted neuroadaptive cognitive training with neuroplasticity-based software created by Posit Science Corporation. Receives: Behavioral: Neuroadaptive cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance, as measured by a neuropsychological battery
Measured: Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up
Secondary outcomes (1)
Symptom profile, as measured by clinical interviews
Measured: Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2016
- Study completionMay 2016
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.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sophia Vinogradov, MD, Principal investigator, University of California, San Francisco; San Francisco VA Medical Center; NCIRE - The Veterans Health Research InstituteRachel Loewy, PhD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655239
- Sponsor's protocol ID
- R01MH081051
- Other IDs
- R01MH081051
- Status last verified
- Jan 2019
- First submitted
- 7 Apr 2008
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Loewy R, Fisher M, Schlosser DA, Biagianti B, Stuart B, Mathalon DH, Vinogradov S. Intensive Auditory Cognitive Training Improves Verbal Memory in Adolescents and Young Adults at Clinical High Risk for Psychosis. Schizophr Bull. 2016 Jul;42 Suppl 1(Suppl 1):S118-26. doi: 10.1093/schbul/sbw009. Epub 2016 Feb 22.
PubMed 26903238
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroscience-Guided Cognitive Remediation in Adolescents at Risk for Psychosis
- ClinicalTrials.gov ID
- NCT00655239
- Acronym / sponsor ID
- R01MH081051
- Conditions
- Schizophrenia
- Keywords
- Ultra High Risk of Schizophrenia, Prodrome, Psychosis, Schizophrenia, Cognitive Remediation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2008
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 9 Apr 2008 (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 study will evaluate the effectiveness of intensive computerized cognitive training in preventing the onset of psychotic disorder and improving adaptive functioning in adolescents at high risk of schizophrenia.
Detailed description
Schizophrenia is a severe mental disorder that is marked by significant disruption in a person's thought and emotional processes, frequently involving psychotic features. Identifying behavioral changes and symptoms that indicate the beginning stages of schizophrenia is important for early intervention and prevention of a full psychotic episode. These initial symptoms, known as the prodromal symptoms of psychosis, may include odd behaviors, increased social withdrawal, difficulty concentrating, inappropriate emotional responses, suspicion of others, and dramatic sleep and appetite changes. Common treatments for adolescents demonstrating prodromal symptoms include forms of psychotherapy, nutritional training, and low doses of medication. As a form of psychotherapy, neuroadaptive cognitive training exercises delivered on a computer may be the most effective means of remediating the thinking difficulties of adolescents who are experiencing prodromal symptoms and are at risk for developing a first psychotic episode. This study will evaluate the effectiveness of intensive computerized neuroadaptive cognitive training exercises in preventing the onset of psychotic disorder and improving adaptive functioning in adolescents at high risk of schizophrenia.
Participation in this study will last 24 months and will involve both healthy participants and participants at high risk of schizophrenia. Healthy participants will only participate for 12 months. All participants will undergo baseline assessments that will include an interview, written tests, blood draws, and electroencephalogram (EEG) and magnetic resonance imaging (MRI) scans. Participants at high risk of schizophrenia will then be assigned randomly to receive treatment with either computerized neuroadaptive cognitive training or commercially available computer games. Healthy participants will receive treatment with computerized neuroadaptive cognitive training only. All participants will be asked to complete 60-minute sessions of their assigned treatments 5 days per week for 8 weeks. For participants receiving cognitive training, exercises will focus on improving speed and accuracy in the perception of and response to verbal and visuospatial targets. The treatment will focus on targeted cognitive training (TCT). Participants assigned to practice computer games will play standard, commercially available games, with no targeted response.
Participants will repeat baseline assessments at post treatment and Month 6 of follow-up. The EEG and MRI will be repeated only at the Week 8 assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, healthy controls will be complete, and the at risk participants will continue to be followed up out to 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Computer gamesParticipants will use commercially available computer games. |
| Active | Experimental | Behavioral: Neuroadaptive cognitive trainingParticipants will receive targeted neuroadaptive cognitive training with neuroplasticity-based software created by Posit Science Corporation. |
| Healthy Control | Active comparator | Behavioral: Neuroadaptive cognitive trainingHealthy participants will receive targeted neuroadaptive cognitive training with neuroplasticity-based software created by Posit Science Corporation. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Meets criteria from the Structured Interview of Prodromal Syndromes for the diagnosis of a prodromal syndrome
- Good general physical health
- English is first language
- Clinically stable (e.g., outpatient status for at least 8 weeks before study entry;on stable doses of medications for at least 1 month before study entry)
Key exclusion criteria (1 listed)
- Confirmed neurological disorder
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 |
|---|---|---|
| Neuroadaptive cognitive trainingNeuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT. | Behavioural | Active, Healthy Control |
| Computer gamesThe control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 8 weeks. | Behavioural | Control |
Primary outcome
Cognitive performance, as measured by a neuropsychological battery
Time frame: Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up
1 secondary outcome
Symptom profile, as measured by clinical interviews
Time frame: Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up
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 8 Jan 2019.
- Derived from this study: PubMed 26903238Loewy R, Fisher M, Schlosser DA, Biagianti B, Stuart B, Mathalon DH, Vinogradov S. Intensive Auditory Cognitive Training Improves Verbal Memory in Adolescents and Young Adults at Clinical High Risk for Psychosis. Schizophr Bull. 2016 Jul;42 Suppl 1(Suppl 1):S118-26. doi: 10.1093/schbul/sbw009. Epub 2016 Feb 22.
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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.
Sophia Vinogradov, MD principal investigator
University of California, San Francisco; San Francisco VA Medical Center; NCIRE - The Veterans Health Research Institute
Rachel Loewy, PhD study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroadaptive cognitive training and Computer games in people with Schizophrenia, run by University of California, San Francisco 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 1 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 8 Jan 2019. 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?
Cognitive performance, as measured by a neuropsychological battery (time frame: Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up). 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 NCT00655239, 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 8 Jan 2019.