SchizophreniaPhase 4NCT00333177
Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia
A Phase 4 study testing Cognitive remediation training (CT), Healthy behavior training (HBT) and Risperidone, administered orally (Oral Ris) in people with Schizophrenia, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will determine the effectiveness of various combinations of psychosocial therapy and risperidone treatment in improving work or school performance in people with first-episode schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cognitive remediation training (CT), Healthy behavior training (HBT) and Risperidone, administered orally (Oral Ris)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder
- First major episode of psychotic symptoms occurred within 2 years prior to study entry
Who cannot join
- Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)
- Mental retardation (e.g., premorbid intelligence quotient (IQ) less than 70)
- Significant alcohol or substance use during last 6 months
- Unable to complete research measures in English
- Any condition that may make risperidone use medically inadvisable
Trial locations and contacts
1 site in 1 country.
United States1 site
Semel Institute for Neuroscience and Human Behavior at UCLA
Los Angeles, California, 90095
About this study
Official title: Developmental Processes in Schizophrenic Disorders: Cognitive Remediation, Medication Adherence, and Work Outcome in Recent-Onset Schizophrenia
This study will determine the effectiveness of various combinations of psychosocial therapy and risperidone treatment in improving work or school performance in people with first-episode schizophrenia.
Read the detailed description
Schizophrenia is a chronic, severe, and disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. These symptoms make it difficult to maintain a job, participate in school, and keep up self-care. Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis. Antipsychotic medications, such as risperidone, and psychosocial treatments, such as cognitive enhancement training and health behavior training, are common, effective treatments for schizophrenia. This study will determine the effectiveness of various combinations of psychosocial therapy and risperidone treatment in improving work or school performance in people with first-episode schizophrenia.
Participants in this open label study will be randomly assigned to receive one of the following four combinations of an antipsychotic medication and a psychosocial treatment: cognitive enhancement training plus oral risperidone; cognitive enhancement training plus long-acting injectable risperidone; health behavior training plus oral risperidone; or health behavior training plus long-acting injectable risperidone. Cognitive enhancement training will entail 2 hours per week of computer-assisted training targeted at improving attention, memory, and problem-solving skills. Additionally, participants will attend a weekly 1-hour group meeting to learn how to apply these skills to work and school situations. Health behavior training will involve 3 hours per week of relaxation training, nutrition education, and physical exercise to enhance wellness. Participants assigned to receive oral risperidone will receive their medication in pill form at the dosage determined to be optimal by the study psychiatrist. Participants assigned to receive injectable risperidone will be given one injection every 2 weeks. Dosages will start at 25 mg per injection and will be adjusted as needed.
Treatment will continue for 1 year following dosage stabilization, which typically occurs 2 to 3 months following study entry. For the first 6 months, participants assigned to receive health behavior training will attend study visits once a week and participants assigned to receive cognitive enhancement training will attend study visits once a week. For the final 6 months, all participants will attend study visits twice weekly. At each visit, participants will receive their assigned psychosocial treatment; attend group therapy; meet with a case manager for counseling and assessment of symptoms, work functioning, and social functioning; and meet with a psychiatrist to monitor medication response. Additional cognitive and health behavior measures will be taken every 6 months to assess treatment effectiveness.
- Conditions
- Schizophrenia
- Being tested
- Cognitive remediation training (CT), Healthy behavior training (HBT), Risperidone, administered orally (Oral Ris), Risperidone, administered via injection (RLAI)
- Keywords
- Schizoaffective Disorder, Depressed Type, Schizophreniform Disorder, First-Episode Schizophrenia, Supported Employment, Cognitive Remediation, Health Behavior Training, Antipsychotic Medication
- 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.
Cognitive remediation training (CT)Behavioural
Cognitive remediation training includes computerized cognitive training plus learning skills group.
Healthy behavior training (HBT)Behavioural
Healthy behavior training includes group skills training in nutrition, exercise, and relaxation.
Risperidone, administered orally (Oral Ris)Drug
Also called Risperdal
Oral risperidone at dosage judged optimal by treating psychiatrist
Risperidone, administered via injection (RLAI)Drug
Also called Risperdal Consta
Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed
| Study group | Role | What they receive |
|---|---|---|
| Cog Remediation, risperidone injection | Experimental | Participants will receive cognitive remediation training plus risperidone, administered via injection. Receives: Behavioral: Cognitive remediation training (CT); Drug: Risperidone, administered via injection (RLAI) |
| Healthy Behavior Training, risperidone injection | Active comparator | Participants will receive health behavior training plus risperidone, administered via injection. Receives: Behavioral: Healthy behavior training (HBT); Drug: Risperidone, administered via injection (RLAI) |
| Cog Remediation, oral risperidone | Experimental | Participants will receive cognitive remediation training plus risperidone administered orally. Receives: Behavioral: Cognitive remediation training (CT); Drug: Risperidone, administered orally (Oral Ris) |
| Healthy Behavior Training, oral risperidone | Active comparator | Participants will receive health behavior training plus risperidone administered orally. Receives: Behavioral: Healthy behavior training (HBT); Drug: Risperidone, administered orally (Oral Ris) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Values presented here are the changes in MCCB Overall Composite T scores from baseline to 12 months, with higher values representing better outcome. Raw test scores are used to generate T-scores and then the seven MCCB domains are combined to generate an Overall Composite T score. MCCB Overall Composite T scores have a mean in the general population of 50 with a standard deviation of 10. Thus, a positive change of 5 T scores is an improvement of half a standard deviation.
Measured: Measured at baseline and 12 months
Work/School Functioning (Global Functioning Scale: Role)
Change in role functioning from baseline to the 6 month point (rated on a scale from 1= Extreme Role Dysfunction to 10 = Superior Role Functioning) is presented here.
Measured: Baseline to 6 months
Average Medication Non-adherence
5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, Medication Event Monitoring System (MEMS) cap readings, plasma assays, and psychiatrist judgements for oral risperidone and timing of injections for long-acting injectable risperidone. Averaged over medication study participation.
Measured: Averaged over study participation (up to 12 months)
Work/School Functioning (Global Functioning Scale: Role)
Changes in role functioning from baseline to 12 months. Ratings on a 10-point scale with 10 being best.
Measured: Baseline to 12 months
Secondary outcomes (7)
Work Behavior Inventory (WBI) Quality of Work/School Performance
Change in rating on quality of work/school performance based on patient, employer, and/or teacher reports. The Quality of Work rating at baseline was subtracted from the same rating at 12 mos. Higher scores are better outcome.
Measured: Baseline to 1 year
Maintenance of Work/School Attendance
Modified Work Section of the Social Adjustment Scale (SAS) was used to calculate the total number of weeks in school or competitive work. Range of possible values is 0 to 52, with higher numbers being better outcome.
Measured: 12 months
Exacerbation or Relapse of Psychotic Symptoms
Dichotomous measure: Presence of any of 3 psychotic relapse or exacerbation categories scored from the Brief Psychiatric Rating Scale (BPRS) occurring after randomization and until end of study participation (up to 12 months post baseline). BPRS was administered every two weeks throughout study participation.
Measured: Occurence after randomization and until end of study participation (up to 12 mos.)
Retention in Treatment
Days after randomization that a participant continued to receive at least the assigned CT or HBT psychosocial treatment. If a participant needed to end the assigned medication condition (RLAI vs. Oral Ris), they continued in the psychosocial treatment so this outcome focused on the days in the assigned psychosocial treatment. Possible range is 1 to 365, with higher being a better outcome.
Measured: 12 months
Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)
Rating scale based on clinician's interview of patient to determine level of lack of awareness of having a mental disorder. Range is from 1 (Aware) to 5 (Unaware), so lower scores indicate better outcome.
Measured: 12 months after randomization
Change in Motivation for Work/School
The Work Motivation scale is a factor score from the Work Personality Profile. The Work Personality Profile is a set of ratings based on interviewing the participant. Scores at each occasion can range from 8 to 32, with higher indicating better motivation. Scores reported here are changes from baseline to 12 months, which could range from -24 to 24 with higher being better.
Measured: Baseline to 12 months
Change in Coping Strategies
Coping Response Inventory, which rates extent to which active coping strategies were used after a significant stressful life event. Range of possible scores is 1 to 4. Higher scores are better.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startMar 2006
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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, Los AngelesThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Janssen Scientific Affairs, LLC
- Responsible party
- Principal investigator, Keith Nuechterlein, Ph.D., University of California, Los Angeles
- Investigators
- Keith H. Nuechterlein, PhD, Principal investigator, University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333177
- Sponsor's protocol ID
- R01MH037705-06
- Other IDs
- R01MH037705, DAHBR AD-P
- Status last verified
- Mar 2020
- First submitted
- 1 Jun 2006
- Last updated
- 26 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Novacek DM, Subotnik KL, Ventura J, Casaus LR, Whelan F, Sugar CA, Nuechterlein KH. Positive symptoms and medication adherence in response to oral versus long-acting injectable risperidone in black, latino, and white first-episode psychosis patients. Schizophr Res. 2025 Oct;284:160-166. doi: 10.1016/j.schres.2025.08.004. Epub 2025 Aug 7.
PubMed 40779812Nuechterlein KH, Ventura J, Subotnik KL, Gretchen-Doorly D, Turner LR, Casaus LR, Luo J, Boucher ML, Hayata JN, Bell MD, Medalia A. A randomized controlled trial of cognitive remediation and long-acting injectable risperidone after a first episode of schizophrenia: improving cognition and work/school functioning. Psychol Med. 2022 Jun;52(8):1517-1526. doi: 10.1017/S0033291720003335. Epub 2020 Sep 28.
PubMed 32981534Subotnik KL, Casaus LR, Ventura J, Luo JS, Hellemann GS, Gretchen-Doorly D, Marder S, Nuechterlein KH. Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia. A Randomized Clinical Trial. JAMA Psychiatry. 2015 Aug;72(8):822-9. doi: 10.1001/jamapsychiatry.2015.0270.
PubMed 26107752
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Processes in Schizophrenic Disorders: Cognitive Remediation, Medication Adherence, and Work Outcome in Recent-Onset Schizophrenia
- ClinicalTrials.gov ID
- NCT00333177
- Acronym / sponsor ID
- R01MH037705-06
- Conditions
- Schizophrenia
- Keywords
- Schizoaffective Disorder, Depressed Type, Schizophreniform Disorder, First-Episode Schizophrenia, Supported Employment, Cognitive Remediation, Health Behavior Training, Antipsychotic Medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Janssen Scientific Affairs, LLC
- Study start
- Mar 2006
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Jun 2006 (estimated)
- Results
- Posted 26 Mar 2020
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 determine the effectiveness of various combinations of psychosocial therapy and risperidone treatment in improving work or school performance in people with first-episode schizophrenia.
Detailed description
Schizophrenia is a chronic, severe, and disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. These symptoms make it difficult to maintain a job, participate in school, and keep up self-care. Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis. Antipsychotic medications, such as risperidone, and psychosocial treatments, such as cognitive enhancement training and health behavior training, are common, effective treatments for schizophrenia. This study will determine the effectiveness of various combinations of psychosocial therapy and risperidone treatment in improving work or school performance in people with first-episode schizophrenia.
Participants in this open label study will be randomly assigned to receive one of the following four combinations of an antipsychotic medication and a psychosocial treatment: cognitive enhancement training plus oral risperidone; cognitive enhancement training plus long-acting injectable risperidone; health behavior training plus oral risperidone; or health behavior training plus long-acting injectable risperidone. Cognitive enhancement training will entail 2 hours per week of computer-assisted training targeted at improving attention, memory, and problem-solving skills. Additionally, participants will attend a weekly 1-hour group meeting to learn how to apply these skills to work and school situations. Health behavior training will involve 3 hours per week of relaxation training, nutrition education, and physical exercise to enhance wellness. Participants assigned to receive oral risperidone will receive their medication in pill form at the dosage determined to be optimal by the study psychiatrist. Participants assigned to receive injectable risperidone will be given one injection every 2 weeks. Dosages will start at 25 mg per injection and will be adjusted as needed.
Treatment will continue for 1 year following dosage stabilization, which typically occurs 2 to 3 months following study entry. For the first 6 months, participants assigned to receive health behavior training will attend study visits once a week and participants assigned to receive cognitive enhancement training will attend study visits once a week. For the final 6 months, all participants will attend study visits twice weekly. At each visit, participants will receive their assigned psychosocial treatment; attend group therapy; meet with a case manager for counseling and assessment of symptoms, work functioning, and social functioning; and meet with a psychiatrist to monitor medication response. Additional cognitive and health behavior measures will be taken every 6 months to assess treatment effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cog Remediation, risperidone injection | Experimental | Behavioral: Cognitive remediation training (CT), Drug: Risperidone, administered via injection (RLAI)Participants will receive cognitive remediation training plus risperidone, administered via injection. |
| Healthy Behavior Training, risperidone injection | Active comparator | Behavioral: Healthy behavior training (HBT), Drug: Risperidone, administered via injection (RLAI)Participants will receive health behavior training plus risperidone, administered via injection. |
| Cog Remediation, oral risperidone | Experimental | Behavioral: Cognitive remediation training (CT), Drug: Risperidone, administered orally (Oral Ris)Participants will receive cognitive remediation training plus risperidone administered orally. |
| Healthy Behavior Training, oral risperidone | Active comparator | Behavioral: Healthy behavior training (HBT), Drug: Risperidone, administered orally (Oral Ris)Participants will receive health behavior training plus risperidone administered orally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder
- First major episode of psychotic symptoms occurred within 2 years prior to study entry
Key exclusion criteria (5 listed)
- Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)
- Mental retardation (e.g., premorbid intelligence quotient (IQ) less than 70)
- Significant alcohol or substance use during last 6 months
- Unable to complete research measures in English
- Any condition that may make risperidone use medically inadvisable
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 training (CT)Cognitive remediation training includes computerized cognitive training plus learning skills group. | Behavioural | Cog Remediation, oral risperidone, Cog Remediation, risperidone injection |
| Healthy behavior training (HBT)Healthy behavior training includes group skills training in nutrition, exercise, and relaxation. | Behavioural | Healthy Behavior Training, oral risperidone, Healthy Behavior Training, risperidone injection |
| Risperidone, administered orally (Oral Ris)Also: RisperdalOral risperidone at dosage judged optimal by treating psychiatrist | Drug | Cog Remediation, oral risperidone, Healthy Behavior Training, oral risperidone |
| Risperidone, administered via injection (RLAI)Also: Risperdal ConstaRisperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed | Drug | Cog Remediation, risperidone injection, Healthy Behavior Training, risperidone injection |
Primary outcome
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: Measured at baseline and 12 months
Values presented here are the changes in MCCB Overall Composite T scores from baseline to 12 months, with higher values representing better outcome. Raw test scores are used to generate T-scores and then the seven MCCB domains are combined to generate an Overall Composite T score. MCCB Overall Composite T scores have a mean in the general population of 50 with a standard deviation of 10. Thus, a positive change of 5 T scores is an improvement of half a standard deviation.
Work/School Functioning (Global Functioning Scale: Role)
Time frame: Baseline to 6 months
Change in role functioning from baseline to the 6 month point (rated on a scale from 1= Extreme Role Dysfunction to 10 = Superior Role Functioning) is presented here.
Average Medication Non-adherence
Time frame: Averaged over study participation (up to 12 months)
5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, Medication Event Monitoring System (MEMS) cap readings, plasma assays, and psychiatrist judgements for oral risperidone and timing of injections for long-acting injectable risperidone. Averaged over medication study participation.
Work/School Functioning (Global Functioning Scale: Role)
Time frame: Baseline to 12 months
Changes in role functioning from baseline to 12 months. Ratings on a 10-point scale with 10 being best.
7 secondary outcomes
Work Behavior Inventory (WBI) Quality of Work/School Performance
Time frame: Baseline to 1 year
Maintenance of Work/School Attendance
Time frame: 12 months
Exacerbation or Relapse of Psychotic Symptoms
Time frame: Occurence after randomization and until end of study participation (up to 12 mos.)
Retention in Treatment
Time frame: 12 months
Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)
Time frame: 12 months after randomization
Change in Motivation for Work/School
Time frame: Baseline to 12 months
Change in Coping Strategies
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40779812Novacek DM, Subotnik KL, Ventura J, Casaus LR, Whelan F, Sugar CA, Nuechterlein KH. Positive symptoms and medication adherence in response to oral versus long-acting injectable risperidone in black, latino, and white first-episode psychosis patients. Schizophr Res. 2025 Oct;284:160-166. doi: 10.1016/j.schres.2025.08.004. Epub 2025 Aug 7.
- Derived from this study: PubMed 32981534Nuechterlein KH, Ventura J, Subotnik KL, Gretchen-Doorly D, Turner LR, Casaus LR, Luo J, Boucher ML, Hayata JN, Bell MD, Medalia A. A randomized controlled trial of cognitive remediation and long-acting injectable risperidone after a first episode of schizophrenia: improving cognition and work/school functioning. Psychol Med. 2022 Jun;52(8):1517-1526. doi: 10.1017/S0033291720003335. Epub 2020 Sep 28.
- Derived from this study: PubMed 26107752Subotnik KL, Casaus LR, Ventura J, Luo JS, Hellemann GS, Gretchen-Doorly D, Marder S, Nuechterlein KH. Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia. A Randomized Clinical Trial. JAMA Psychiatry. 2015 Aug;72(8):822-9. doi: 10.1001/jamapsychiatry.2015.0270.
- Individual participant dataSharing planned: No
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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.
Keith H. Nuechterlein, PhD principal investigator
University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive remediation training (CT), Healthy behavior training (HBT) and Risperidone, administered orally (Oral Ris) in people with Schizophrenia, run by University of California, Los Angeles 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 2 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 26 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) (time frame: Measured at baseline and 12 months). The study lists 4 primary outcomes in all. 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 NCT00333177, which also lists 3 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 Mar 2020.