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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH037705 | U.S. NIH Grant/Contract | View source | |
| DAHBR AD-P | Registry Identifier | WHO ICTRP |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Janssen Scientific Affairs, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cog Remediation, risperidone injection | Experimental | Participants will receive cognitive remediation training plus risperidone, administered via injection. |
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| Healthy Behavior Training, risperidone injection | Active Comparator | Participants will receive health behavior training plus risperidone, administered via injection. |
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| Cog Remediation, oral risperidone | Experimental | Participants will receive cognitive remediation training plus risperidone administered orally. |
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| Healthy Behavior Training, oral risperidone | Active Comparator | Participants will receive health behavior training plus risperidone administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive remediation training (CT) | Behavioral | Cognitive remediation training includes computerized cognitive training plus learning skills group. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | 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. | 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. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith H. Nuechterlein, PhD | University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semel Institute for Neuroscience and Human Behavior at UCLA | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32981534 | Derived | Nuechterlein 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. | |
| 26107752 | Derived | Subotnik 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. |
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32 patients who were enrolled in the study dropped out during the initial medication stabilization period prior to the start of randomized treatment resulting in 60 being assigned to the randomized treatments.
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| ID | Title | Description |
|---|---|---|
| FG000 | CT - RLAI | Participants will receive cognitive remediation training (CT) plus injectable, long-acting risperidone (RLAI). Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group. Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed Individual Placement and Support: Supported education/employment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Healthy behavior training (HBT) | Behavioral | Healthy behavior training includes group skills training in nutrition, exercise, and relaxation. |
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| Risperidone, administered orally (Oral Ris) | Drug | Oral risperidone at dosage judged optimal by treating psychiatrist |
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| Risperidone, administered via injection (RLAI) | Drug | Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | Baseline to 12 months |
| FG001 | HBT - RLAI | Participants will receive health behavior training (HBT) plus injectable, long-acting risperidone (RLAI). Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed Individual Placement and Support: Supported education/employment |
| FG002 | CT - Oral Ris | Participants will receive cognitive remediation training (CT) plus risperidone administered orally (Oral Ris). Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
| FG003 | HBT - Oral Ris | Participants will receive health behavior training (HBT) plus risperidone administered orally (Oral Ris). Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
| Received Intervention |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CT - RLAI | Participants will receive cognitive remediation training plus injectable, long-acting risperidone. Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group. Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed Individual Placement and Support: Supported education/employment |
| BG001 | HBT - RLAI | Participants will receive health behavior training plus injectable, long-acting risperidone. Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed Individual Placement and Support: Supported education/employment |
| BG002 | CT - Oral Ris | Participants will receive cognitive remediation training plus risperidone administered orally. Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
| BG003 | HBT - Oral Ris | Participants will receive health behavior training plus risperidone administered orally. Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants with MCCB outcome data. | Posted | Mean | Standard Error | T scores | Measured at baseline and 12 months |
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| Primary | 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. | Participants who received services from the supported education/employment specialist | Posted | Mean | Standard Deviation | Changes on a 10-point scale | Baseline to 6 months |
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| Primary | 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. | A priori hypothesis was that long-acting injectable risperidone would result in better medication adherence than oral risperidone, so CT and HBT groups were merged within each medication administration condition. | Posted | Mean | Standard Deviation | units on a 5-point scale | Averaged over study participation (up to 12 months) |
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| Primary | 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. | Participants who received services from the Individual Placement and Support specialist. | Posted | Mean | Standard Deviation | Changes on a 10-point scale | Baseline to 12 months |
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| Secondary | 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. | This measure could be rated only for individuals who were in school or working at baseline and at 12 months, so it proved not to be useful due to the infrequent return to school or work by baseline. | Posted | Mean | Standard Deviation | score on a rating scale | Baseline to 1 year |
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| Secondary | 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. | Participants who were served by the Individual Placement and Support specialist | Posted | Mean | Standard Deviation | weeks | 12 months |
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| Secondary | 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. | A priori hypothesis was that RLAI would lead to fewer psychotic exacerbations/relapses than Oral Ris. No effect of CT vs. HBT was hypothesized, so CT and HBT conditions were merged within each medication administration condition. | Posted | Number | participants | Occurence after randomization and until end of study participation (up to 12 mos.) |
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| Secondary | 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. | All participants who received Individual Placement and Support | Posted | Mean | Standard Deviation | days | 12 months |
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| Secondary | 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. | All participants with SUMD-R data at 12-month point. | Posted | Mean | Standard Deviation | score on a scale | 12 months after randomization |
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| Secondary | 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. | Participants in school or jobs at baseline and 12 months, which allows change in Work Personality Profile ratings to be assessed. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Secondary | 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. | Participants with Coping Response Inventories completed for a comparable stressful life event at baseline and 12 months. This was so rare in practice that this outcome was not feasible to evaluate. | Posted | Baseline to 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT - RLAI | Participants will receive cognitive remediation training plus injectable, long-acting risperidone. Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group. Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed Individual Placement and Support: Supported education/employment | 1 | 12 | 5 | 12 | ||
| EG001 | HBT - RLAI | Participants will receive health behavior training plus injectable, long-acting risperidone. Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered via injection: Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed Individual Placement and Support: Supported education/employment | 0 | 16 | 5 | 16 | ||
| EG002 | CT - Oral Ris | Participants will receive cognitive remediation training plus risperidone administered orally. Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment | 3 | 16 | 11 | 16 | ||
| EG003 | HBT - Oral Ris | Participants will receive health behavior training plus risperidone administered orally. Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment | 1 | 12 | 6 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| psychiatric hospitalization | Psychiatric disorders | Systematic Assessment | psychiatric hospitalization |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BMI increase normal/overweight to Obese | Metabolism and nutrition disorders | Systematic Assessment | Increase in BMI from normal/overweight to any Obese category |
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| LDL or Triglyceride increase | Cardiac disorders | Systematic Assessment | increase from normal to high in either LDL or Triglyceride |
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| TD early signs | Nervous system disorders | Systematic Assessment | Early signs of mild tardive dyskinesia |
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| Prolactin related symptom | Endocrine disorders | Systematic Assessment | Symptom related to prolactin level |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith H. Nuechterlein, Ph.D., Principal Investigator | University of California, Los Angeles | (310) 825-0036 | keithn@ucla.edu |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants will receive cognitive remediation training plus risperidone administered orally. Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
| OG003 | HBT - Oral Ris | Participants will receive health behavior training plus risperidone administered orally. Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
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Participants will receive cognitive remediation training plus risperidone administered orally.
Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group.
Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist
Individual Placement and Support: Supported education/employment
| OG003 | HBT - Oral Ris | Participants will receive health behavior training plus risperidone administered orally. Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
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| OG002 | CT - Oral Ris | Participants will receive cognitive remediation training plus risperidone administered orally. Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
| OG003 | HBT - Oral Ris | Participants will receive health behavior training plus risperidone administered orally. Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
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Participants will receive cognitive remediation training plus risperidone administered orally. Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
| OG003 | HBT - Oral Ris | Participants will receive health behavior training plus risperidone administered orally. Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
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| OG002 | CT - Oral Ris | Participants will receive cognitive remediation training plus risperidone administered orally. Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
| OG003 | HBT - Oral Ris | Participants will receive health behavior training plus risperidone administered orally. Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
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| CT - Oral Ris |
Participants will receive cognitive remediation training plus risperidone administered orally. Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
| OG003 | HBT - Oral Ris | Participants will receive health behavior training plus risperidone administered orally. Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
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| OG002 | CT - Oral Ris | Participants will receive cognitive remediation training plus risperidone administered orally. Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
| OG003 | HBT - Oral Ris | Participants will receive health behavior training plus risperidone administered orally. Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
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| CT - Oral Ris |
Participants will receive cognitive remediation training plus risperidone administered orally. Cognitive remediation: Cognitive remediation training includes computerized cognitive training plus learning skills group. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
| OG003 | HBT - Oral Ris | Participants will receive health behavior training plus risperidone administered orally. Health behavior training: Health behavior training includes group skills training in nutrition, exercise, and relaxation. Risperidone, administered orally: Oral risperidone at dosage judged optimal by treating psychiatrist Individual Placement and Support: Supported education/employment |
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