Trial Outcomes & Findings for Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia (NCT NCT00330551)
NCT ID: NCT00330551
Last Updated: 2023-03-01
Results Overview
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.).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
126 participants
Primary outcome timeframe
Occurrence after randomization and until end of study participation (up to 12 mos.)
Results posted on
2023-03-01
Participant Flow
Of the 126 eligible and enrolled participants, 43 dropped out prior to the start of randomized treatment, resulting in 83 randomized.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
43
|
|
Overall Study
COMPLETED
|
30
|
27
|
|
Overall Study
NOT COMPLETED
|
10
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
Baseline characteristics by cohort
| Measure |
Long-acting Injectable Risperidone
n=40 Participants
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.
|
Oral Risperidone
n=43 Participants
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.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21.9 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
21.1 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
21.5 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
43 participants
n=7 Participants
|
83 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured weekly throughout study participation, averaged over study participation5-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
Outcome measures
| Measure |
Long-acting Injectable Risperidone
n=40 Participants
Participants who are randomly assigned to this arm will be administered the long-acting injectable form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.
Risperidone in Long-Acting Injectable Form (Consta): 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.
|
Oral Risperidone
n=43 Participants
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.
|
|---|---|---|
|
Medication Adherence
|
1.1 units on a scale
Standard Deviation 0.5
|
1.9 units on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: Occurrence after randomization and until end of study participation (up to 12 mos.)Population: All participants randomized to long-acting injectable or oral risperidone
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.).
Outcome measures
| Measure |
Long-acting Injectable Risperidone
n=40 Participants
Participants who are randomly assigned to this arm will be administered the long-acting injectable form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.
Risperidone in Long-Acting Injectable Form (Consta): 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.
|
Oral Risperidone
n=43 Participants
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.
|
|---|---|---|
|
Number of Participants Who Had an Exacerbation or Relapse of Psychotic Symptoms
|
2 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Measured from Baseline to Month 12Population: All participants with data regarding return to work or school
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.
Outcome measures
| Measure |
Long-acting Injectable Risperidone
n=37 Participants
Participants who are randomly assigned to this arm will be administered the long-acting injectable form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.
Risperidone in Long-Acting Injectable Form (Consta): 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.
|
Oral Risperidone
n=38 Participants
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.
|
|---|---|---|
|
Number of Participants Who Returned to Work or School (SAS Work Section)
|
29 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: Cumulative total measured from Baseline to Month 12Population: All participants with data on duration of work or school
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.
Outcome measures
| Measure |
Long-acting Injectable Risperidone
n=37 Participants
Participants who are randomly assigned to this arm will be administered the long-acting injectable form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.
Risperidone in Long-Acting Injectable Form (Consta): 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.
|
Oral Risperidone
n=41 Participants
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.
|
|---|---|---|
|
Number of Weeks Maintaining Work or School (SAS)
|
26.7 weeks
Standard Deviation 20.4
|
21.1 weeks
Standard Deviation 18.0
|
PRIMARY outcome
Timeframe: Measured at Baseline and Month 12Population: All participants with Global Functioning Scale: Role ratings at baseline and 12 months
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.
Outcome measures
| Measure |
Long-acting Injectable Risperidone
n=29 Participants
Participants who are randomly assigned to this arm will be administered the long-acting injectable form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.
Risperidone in Long-Acting Injectable Form (Consta): 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.
|
Oral Risperidone
n=30 Participants
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.
|
|---|---|---|
|
Change in Global Functioning Scale: Role
|
1.5 Changes on a 10-point scale
Standard Deviation 2.7
|
1.2 Changes on a 10-point scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Measured at baseline and 12 monthsPopulation: All participants with MCCB Overall Composite scores at baseline and 12 months
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.
Outcome measures
| Measure |
Long-acting Injectable Risperidone
n=29 Participants
Participants who are randomly assigned to this arm will be administered the long-acting injectable form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.
Risperidone in Long-Acting Injectable Form (Consta): 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.
|
Oral Risperidone
n=32 Participants
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.
|
|---|---|---|
|
MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score
|
3.5 Change score: change in T scores
Standard Deviation 7.5
|
4.4 Change score: change in T scores
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Measured from Baseline to Month 12Population: No data were available because this part of the initial proposal was not funded.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 12 monthsPopulation: All participants randomized to oral vs. long-acting injectable risperidone
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.
Outcome measures
| Measure |
Long-acting Injectable Risperidone
n=40 Participants
Participants who are randomly assigned to this arm will be administered the long-acting injectable form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.
Risperidone in Long-Acting Injectable Form (Consta): 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.
|
Oral Risperidone
n=43 Participants
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.
|
|---|---|---|
|
Retention in Treatment
|
307.6 days
Standard Deviation 108.3
|
270.7 days
Standard Deviation 126.4
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: All participants with ratings at baseline and 12 months, with 6-month rating carried forward if no 12-month rating was completed.
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.
Outcome measures
| Measure |
Long-acting Injectable Risperidone
n=30 Participants
Participants who are randomly assigned to this arm will be administered the long-acting injectable form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.
Risperidone in Long-Acting Injectable Form (Consta): 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.
|
Oral Risperidone
n=34 Participants
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.
|
|---|---|---|
|
Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder-Revised (SUMD-R)
|
.07 Change scores on 5-point rating scale
Standard Deviation 1.34
|
-.24 Change scores on 5-point rating scale
Standard Deviation 1.56
|
Adverse Events
Long-acting Injectible Risperidone
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Oral Risperidone
Serious events: 8 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Long-acting Injectible Risperidone
n=40 participants at risk
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.
|
Oral Risperidone
n=43 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
psychiatric hospitalization
|
5.0%
2/40 • Number of events 2
|
18.6%
8/43 • Number of events 8
|
Other adverse events
| Measure |
Long-acting Injectible Risperidone
n=40 participants at risk
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.
|
Oral Risperidone
n=43 participants at risk
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.
|
|---|---|---|
|
Metabolism and nutrition disorders
BMI increase from normal or overweight to Obese
|
17.5%
7/40 • Number of events 7
|
11.6%
5/43 • Number of events 5
|
|
Vascular disorders
Lipid Increase
|
5.0%
2/40 • Number of events 2
|
20.9%
9/43 • Number of events 9
|
|
Nervous system disorders
Tardive Dyskinesia
|
5.0%
2/40 • Number of events 2
|
7.0%
3/43 • Number of events 3
|
|
Endocrine disorders
Prolactin related
|
7.5%
3/40 • Number of events 3
|
9.3%
4/43 • Number of events 4
|
Additional Information
Keith Nuechterlein, PhD
University of California, Los Angeles
Phone: (310) 825-0036
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place