Trial Outcomes & Findings for Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia (NCT NCT00333177)
NCT ID: NCT00333177
Last Updated: 2020-03-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
92 participants
Primary outcome timeframe
Measured at baseline and 12 months
Results posted on
2020-03-26
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
17
|
17
|
14
|
|
Overall Study
Received Intervention
|
12
|
16
|
16
|
12
|
|
Overall Study
COMPLETED
|
12
|
16
|
16
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia
Baseline characteristics by cohort
| Measure |
CT - RLAI
n=12 Participants
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
|
HBT - RLAI
n=17 Participants
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
|
CT - Oral Ris
n=17 Participants
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
|
HBT - Oral Ris
n=14 Participants
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
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
21.7 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
22.1 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
21.3 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
20.8 years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
21.9 years
STANDARD_DEVIATION 3.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
17 participants
n=7 Participants
|
17 participants
n=5 Participants
|
14 participants
n=4 Participants
|
60 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and 12 monthsPopulation: All participants with MCCB outcome data.
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.
Outcome measures
| Measure |
CT - RLAI
n=12 Participants
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
|
HBT - RLAI
n=16 Participants
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
|
CT - Oral Ris
n=16 Participants
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
|
HBT - Oral Ris
n=12 Participants
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
|
|---|---|---|---|---|
|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
|
6.7 T scores
Standard Error 1.9
|
0.9 T scores
Standard Error 1.6
|
3.9 T scores
Standard Error 1.6
|
5.9 T scores
Standard Error 1.9
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants who received services from the supported education/employment specialist
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.
Outcome measures
| Measure |
CT - RLAI
n=10 Participants
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
|
HBT - RLAI
n=12 Participants
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
|
CT - Oral Ris
n=15 Participants
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
|
HBT - Oral Ris
n=11 Participants
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
|
|---|---|---|---|---|
|
Work/School Functioning (Global Functioning Scale: Role)
|
2.90 Changes on a 10-point scale
Standard Deviation 2.56
|
0.92 Changes on a 10-point scale
Standard Deviation 2.75
|
1.27 Changes on a 10-point scale
Standard Deviation 2.76
|
-0.82 Changes on a 10-point scale
Standard Deviation 2.93
|
PRIMARY outcome
Timeframe: Averaged over study participation (up to 12 months)Population: 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.
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.
Outcome measures
| Measure |
CT - RLAI
n=28 Participants
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
|
HBT - RLAI
n=27 Participants
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
|
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
|
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
|
|---|---|---|---|---|
|
Average Medication Non-adherence
|
1.0 units on a 5-point scale
Standard Deviation 0.1
|
1.9 units on a 5-point scale
Standard Deviation 0.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants who received services from the Individual Placement and Support specialist.
Changes in role functioning from baseline to 12 months. Ratings on a 10-point scale with 10 being best.
Outcome measures
| Measure |
CT - RLAI
n=10 Participants
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
|
HBT - RLAI
n=13 Participants
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
|
CT - Oral Ris
n=14 Participants
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
|
HBT - Oral Ris
n=11 Participants
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
|
|---|---|---|---|---|
|
Work/School Functioning (Global Functioning Scale: Role)
|
2.70 Changes on a 10-point scale
Standard Deviation 2.67
|
1.69 Changes on a 10-point scale
Standard Deviation 2.66
|
2.43 Changes on a 10-point scale
Standard Deviation 2.44
|
0.18 Changes on a 10-point scale
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: Baseline to 1 yearPopulation: 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.
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.
Outcome measures
| Measure |
CT - RLAI
n=2 Participants
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
|
HBT - RLAI
n=6 Participants
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
|
CT - Oral Ris
n=8 Participants
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
|
HBT - Oral Ris
n=2 Participants
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
|
|---|---|---|---|---|
|
Work Behavior Inventory (WBI) Quality of Work/School Performance
|
-6.5 score on a rating scale
Standard Deviation 31.8
|
8.8 score on a rating scale
Standard Deviation 34.0
|
-3.4 score on a rating scale
Standard Deviation 17.4
|
0.0 score on a rating scale
Standard Deviation 33.9
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants who were served by the Individual Placement and Support specialist
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.
Outcome measures
| Measure |
CT - RLAI
n=12 Participants
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
|
HBT - RLAI
n=16 Participants
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
|
CT - Oral Ris
n=16 Participants
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
|
HBT - Oral Ris
n=12 Participants
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
|
|---|---|---|---|---|
|
Maintenance of Work/School Attendance
|
35.4 weeks
Standard Deviation 21.2
|
24.4 weeks
Standard Deviation 19.8
|
26.7 weeks
Standard Deviation 20.0
|
12.0 weeks
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: Occurence after randomization and until end of study participation (up to 12 mos.)Population: 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.
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.
Outcome measures
| Measure |
CT - RLAI
n=28 Participants
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
|
HBT - RLAI
n=28 Participants
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
|
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
|
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
|
|---|---|---|---|---|
|
Exacerbation or Relapse of Psychotic Symptoms
|
2 participants
|
10 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants who received Individual Placement and Support
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.
Outcome measures
| Measure |
CT - RLAI
n=12 Participants
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
|
HBT - RLAI
n=16 Participants
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
|
CT - Oral Ris
n=16 Participants
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
|
HBT - Oral Ris
n=12 Participants
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
|
|---|---|---|---|---|
|
Retention in Treatment
|
359.7 days
Standard Deviation 8.1
|
352.2 days
Standard Deviation 26.9
|
332.4 days
Standard Deviation 38.8
|
348.3 days
Standard Deviation 28.4
|
SECONDARY outcome
Timeframe: 12 months after randomizationPopulation: All participants with SUMD-R data at 12-month point.
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 |
CT - RLAI
n=4 Participants
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
|
HBT - RLAI
n=7 Participants
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
|
CT - Oral Ris
n=6 Participants
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
|
HBT - Oral Ris
n=4 Participants
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
|
|---|---|---|---|---|
|
Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)
|
1.25 score on a scale
Standard Deviation 0.50
|
3.29 score on a scale
Standard Deviation 1.80
|
2.00 score on a scale
Standard Deviation 1.67
|
3.75 score on a scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants in school or jobs at baseline and 12 months, which allows change in Work Personality Profile ratings to be assessed.
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.
Outcome measures
| Measure |
CT - RLAI
n=7 Participants
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
|
HBT - RLAI
n=6 Participants
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
|
CT - Oral Ris
n=9 Participants
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
|
HBT - Oral Ris
n=5 Participants
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
|
|---|---|---|---|---|
|
Change in Motivation for Work/School
|
3.7 score on a scale
Standard Deviation 2.3
|
1.2 score on a scale
Standard Deviation 4.6
|
-2.4 score on a scale
Standard Deviation 7.4
|
-1.9 score on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
CT - RLAI
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
HBT - RLAI
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
CT - Oral Ris
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
HBT - Oral Ris
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT - RLAI
n=12 participants at risk
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
|
HBT - RLAI
n=16 participants at risk
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
|
CT - Oral Ris
n=16 participants at risk
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
|
HBT - Oral Ris
n=12 participants at risk
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
|
|---|---|---|---|---|
|
Psychiatric disorders
psychiatric hospitalization
|
8.3%
1/12 • Number of events 1 • 12 months
|
0.00%
0/16 • 12 months
|
18.8%
3/16 • Number of events 3 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
CT - RLAI
n=12 participants at risk
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
|
HBT - RLAI
n=16 participants at risk
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
|
CT - Oral Ris
n=16 participants at risk
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
|
HBT - Oral Ris
n=12 participants at risk
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
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
BMI increase normal/overweight to Obese
|
25.0%
3/12 • Number of events 3 • 12 months
|
12.5%
2/16 • Number of events 2 • 12 months
|
31.2%
5/16 • Number of events 5 • 12 months
|
0.00%
0/12 • 12 months
|
|
Cardiac disorders
LDL or Triglyceride increase
|
8.3%
1/12 • Number of events 1 • 12 months
|
6.2%
1/16 • Number of events 1 • 12 months
|
25.0%
4/16 • Number of events 4 • 12 months
|
41.7%
5/12 • Number of events 5 • 12 months
|
|
Nervous system disorders
TD early signs
|
8.3%
1/12 • Number of events 1 • 12 months
|
6.2%
1/16 • Number of events 1 • 12 months
|
6.2%
1/16 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Endocrine disorders
Prolactin related symptom
|
16.7%
2/12 • Number of events 2 • 12 months
|
6.2%
1/16 • Number of events 1 • 12 months
|
12.5%
2/16 • Number of events 2 • 12 months
|
16.7%
2/12 • Number of events 2 • 12 months
|
Additional Information
Keith H. Nuechterlein, Ph.D., Principal Investigator
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