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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH066286 | U.S. NIH Grant/Contract | View source | |
| DATR A2-AISZ | Registry Identifier | World Health Organization ICTRP | |
| Janssen RIS-NAP-4009 | Other Grant/Funding Number | Janssen Scientific Affairs |
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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 oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.
Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis. People experiencing their first episode of schizophrenia are more responsive to treatment than those with chronic schizophrenia, but are also more susceptible to adverse treatment side effects. Atypical antipsychotic medications have been shown to produce fewer adverse side effects than older "typical" antipsychotics. Risperidone is a type of atypical antipsychotic medication that is used to control the symptoms of schizophrenia. This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.
Participants in this open label study will be randomly assigned to receive either orally administered risperidone or long-acting risperidone administered via injection. Participants assigned to oral risperidone will receive medication in doses that are determined to be optimal by the study psychiatrist. Participants assigned to long-acting risperidone will receive an injection of risperidone once every 2 weeks. Dosages will begin at 25 mg and will be adjusted as necessary to achieve the optimal dosage. Following 2 to 3 months to achieve outpatient risperidone dosage stabilization, the randomized medication conditions will begin and participants will be monitored for 1 year. Study visits will occur once weekly throughout the study. They will include group therapy meetings focused on everyday living skills; family education about schizophrenia; assessments of medication response; and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-acting injectible risperidone | Experimental | Participants who are randomly assigned to this arm will be administered the long-acting injectible form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months. |
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| Oral risperidone | Active Comparator | Participants who are randomly assigned to this arm will be treated with the oral version of risperidone (Risperdal) daily, plus group skills training and case management, for 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Risperidone | Drug | Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence | 5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, MEMS cap readings, plasma assays, and psychiatrist judgments for oral risperidone and timing of injections for long-acting injectable risperidone averaged over study participation | Measured weekly throughout study participation, averaged over study participation |
| Number of Participants Who Had an Exacerbation or Relapse of Psychotic Symptoms | Dichotomous measure: Presence of any of three psychotic relapse or exacerbation categories scored from the Brief Psychiatric Rating Scale (BPRS) occurring any time after randomization and until end of study participation (up to 12 mos.). | Occurrence after randomization and until end of study participation (up to 12 mos.) |
| Number of Participants Who Returned to Work or School (SAS Work Section) | The Social Adjustment Scale records the return to work or school and the number of weeks in work or school during each 3-month period. For this outcome, outcome as dichotomized as 0 if an individual did not return to work or school and 1 if they did return to competitive work or regular school enrollment. | Measured from Baseline to Month 12 |
| Number of Weeks Maintaining Work or School (SAS) | Measured as the number of weeks in which a participant has competitive employment or attends regular school courses. Possible range is 0 to 52 weeks. | Cumulative total measured from Baseline to Month 12 |
| Change in Global Functioning Scale: Role | 10-point scale of work/school functioning. Scale range is from 1 (extreme role dysfunction) to 10 (superior role functioning). Measured by subtracting the baseline rating from the rating at 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score | The MCCB Overall Composite T score is computed by the MCCB Computer Scoring Program from the raw scores for 10 individual cognitive tests. The mean for the general population of comparable age and sex is 50 with a standard deviation of 10. Higher scores indicate better cognitive functioning. The outcome measure was the change from baseline to 12 months, calculated as 12-month T score minus baseline T score. Higher values indicate better outcome. |
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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 |
|---|---|---|---|
| 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. | |
| 21767934 | Derived | Bartzokis G, Lu PH, Amar CP, Raven EP, Detore NR, Altshuler LL, Mintz J, Ventura J, Casaus LR, Luo JS, Subotnik KL, Nuechterlein KH. Long acting injection versus oral risperidone in first-episode schizophrenia: differential impact on white matter myelination trajectory. Schizophr Res. 2011 Oct;132(1):35-41. doi: 10.1016/j.schres.2011.06.029. Epub 2011 Jul 20. |
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Of the 126 eligible and enrolled participants, 43 dropped out prior to the start of randomized treatment, resulting in 83 randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Long-acting Injectable Risperidone | Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms. Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings. Risperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed. |
| FG001 | Oral Risperidone | Participants taking daily oral risperidone, plus group skills training and case management Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms. Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings. Oral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Long-acting Injectable Risperidone | Participants taking risperidone, administered in injectable long-acting form (Risperdal Consta), plus group skills training and case management Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms. Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings. Risperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Medication Adherence | 5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, MEMS cap readings, plasma assays, and psychiatrist judgments for oral risperidone and timing of injections for long-acting injectable risperidone averaged over study participation | Posted | Mean | Standard Deviation | units on a scale | Measured weekly throughout study participation, averaged over study participation |
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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 | Long-acting Injectible Risperidone | Participants taking risperidone, administered in injectible long-acting form (Risperdal Consta), plus group skills training and case management Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms. Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings. Risperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| psychiatric hospitalization | Psychiatric disorders | Systematic Assessment | psychiatric hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BMI increase from normal or overweight to Obese | Metabolism and nutrition disorders | Systematic Assessment | increase in BMI from normal or overweight to any Obese category |
This trial used oral risperidone as the comparator to allow a strong comparison between oral and long-acting injectable forms of the same drug. Generalization of results to other oral antipsychotic medications was not assessed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Nuechterlein, PhD | University of California, Los Angeles | (310) 825-0036 | keithn@ucla.edu |
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| 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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| Risperidone in Long-Acting Injectable Form (Consta) | Drug | Participants will take a 25 mg dosage of injectable risperidone (Risperidone in Long-Acting Injectable Form (Consta)) once every 2 weeks. Dosage will be adjusted if needed. |
|
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| Measured at Baseline and Month 12 |
| Measured at baseline and 12 months |
| Emotional Reactivity on Psychophysiological Measures | Electrodermal reactivity to pictures of negative versus neutral stimuli was the initially proposed measure. Larger skin conductance increases in response to negative pictures compared to neutral pictures would indicate stronger emotional reactivity. | Measured from Baseline to Month 12 |
| Retention in Treatment | Number of days on the randomized medication before being switched to a different antipsychotic medication or dropping out of the medication trial. Possible range is 0 to 365, with higher numbers indicating better retention in treatment. | From baseline to 12 months |
| Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder-Revised (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. | Baseline to 12 months |
| BG001 | Oral Risperidone | Participants taking daily oral risperidone, plus group skills training and case management Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms. Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings. Oral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| 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 |
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| Region of Enrollment | Number | participants |
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| OG001 | Oral Risperidone | Participants who are randomly assigned to this arm will be treated with the oral version of risperidone (Risperdal) daily, plus group skills training and case management, for 12 months. Oral Risperidone: Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist. |
|
|
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| Primary | Number of Participants Who Had an Exacerbation or Relapse of Psychotic Symptoms | Dichotomous measure: Presence of any of three psychotic relapse or exacerbation categories scored from the Brief Psychiatric Rating Scale (BPRS) occurring any time after randomization and until end of study participation (up to 12 mos.). | All participants randomized to long-acting injectable or oral risperidone | Posted | Count of Participants | Participants | Occurrence after randomization and until end of study participation (up to 12 mos.) |
|
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| Primary | Number of Participants Who Returned to Work or School (SAS Work Section) | The Social Adjustment Scale records the return to work or school and the number of weeks in work or school during each 3-month period. For this outcome, outcome as dichotomized as 0 if an individual did not return to work or school and 1 if they did return to competitive work or regular school enrollment. | All participants with data regarding return to work or school | Posted | Count of Participants | Participants | Measured from Baseline to Month 12 |
|
|
|
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| Primary | Number of Weeks Maintaining Work or School (SAS) | Measured as the number of weeks in which a participant has competitive employment or attends regular school courses. Possible range is 0 to 52 weeks. | All participants with data on duration of work or school | Posted | Mean | Standard Deviation | weeks | Cumulative total measured from Baseline to Month 12 |
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| Primary | Change in Global Functioning Scale: Role | 10-point scale of work/school functioning. Scale range is from 1 (extreme role dysfunction) to 10 (superior role functioning). Measured by subtracting the baseline rating from the rating at 12 months. | All participants with Global Functioning Scale: Role ratings at baseline and 12 months | Posted | Mean | Standard Deviation | Changes on a 10-point scale | Measured at Baseline and Month 12 |
|
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|
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| Secondary | MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score | The MCCB Overall Composite T score is computed by the MCCB Computer Scoring Program from the raw scores for 10 individual cognitive tests. The mean for the general population of comparable age and sex is 50 with a standard deviation of 10. Higher scores indicate better cognitive functioning. The outcome measure was the change from baseline to 12 months, calculated as 12-month T score minus baseline T score. Higher values indicate better outcome. | All participants with MCCB Overall Composite scores at baseline and 12 months | Posted | Mean | Standard Deviation | Change score: change in T scores | Measured at baseline and 12 months |
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| Secondary | Emotional Reactivity on Psychophysiological Measures | Electrodermal reactivity to pictures of negative versus neutral stimuli was the initially proposed measure. Larger skin conductance increases in response to negative pictures compared to neutral pictures would indicate stronger emotional reactivity. | No data were available because this part of the initial proposal was not funded. | Posted | Measured from Baseline to Month 12 |
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| Secondary | Retention in Treatment | Number of days on the randomized medication before being switched to a different antipsychotic medication or dropping out of the medication trial. Possible range is 0 to 365, with higher numbers indicating better retention in treatment. | All participants randomized to oral vs. long-acting injectable risperidone | Posted | Mean | Standard Deviation | days | From baseline to 12 months |
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| Secondary | Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder-Revised (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 ratings at baseline and 12 months, with 6-month rating carried forward if no 12-month rating was completed. | Posted | Mean | Standard Deviation | Change scores on 5-point rating scale | Baseline to 12 months |
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| 2 |
| 40 |
| 11 |
| 40 |
| EG001 | Oral Risperidone | Participants taking daily oral risperidone, plus group skills training and case management Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms. Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings. Oral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist. | 8 | 43 | 19 | 43 |
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| Lipid Increase | Vascular disorders | Systematic Assessment | Increase in LDL or Triglycerides from normal to high |
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| Tardive Dyskinesia | Nervous system disorders | Systematic Assessment | New onset of mild symptoms of Tardive Dyskinesia |
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| Prolactin related | Endocrine disorders | Non-systematic Assessment | Symptoms related to prolactin levels |
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