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Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00330551
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Keith Nuechterlein, Ph.D., University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Oral Risperidone
Drug: Risperidone in Long-Acting Injectable Form (Consta)
Enrollment 126
Recruitment Details  
Pre-assignment Details Of the 126 eligible and enrolled participants, 43 dropped out prior to the start of randomized treatment, resulting in 83 randomized.
Arm/Group Title Long-acting Injectable Risperidone Oral Risperidone
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 40 43
Completed 30 27
Not Completed 10 16
Arm/Group Title Long-acting Injectable Risperidone Oral Risperidone Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 40 43 83
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 83 participants
<=18 years
3
   7.5%
9
  20.9%
12
  14.5%
Between 18 and 65 years
37
  92.5%
34
  79.1%
71
  85.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 43 participants 83 participants
21.9  (3.8) 21.1  (3.2) 21.5  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 83 participants
Female
9
  22.5%
9
  20.9%
18
  21.7%
Male
31
  77.5%
34
  79.1%
65
  78.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 83 participants
Hispanic or Latino
15
  37.5%
20
  46.5%
35
  42.2%
Not Hispanic or Latino
25
  62.5%
23
  53.5%
48
  57.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 83 participants
American Indian or Alaska Native
1
   2.5%
3
   7.0%
4
   4.8%
Asian
5
  12.5%
4
   9.3%
9
  10.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   2.3%
1
   1.2%
Black or African American
14
  35.0%
9
  20.9%
23
  27.7%
White
18
  45.0%
23
  53.5%
41
  49.4%
More than one race
2
   5.0%
3
   7.0%
5
   6.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 43 participants 83 participants
40 43 83
1.Primary Outcome
Title Medication Adherence
Hide Description 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
Time Frame Averaged over study participation (up to 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Long-acting Injectable Risperidone Oral Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 40 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.1  (0.5) 1.9  (0.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long-acting Injectable Risperidone, Oral Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter t-test
Estimated Value .77
Confidence Interval (2-Sided) 95%
0.483 to 1.058
Estimation Comments [Not Specified]
Other Statistical Analysis t(80)=5.3, p<.001
2.Primary Outcome
Title Exacerbation or Relapse of Psychotic Symptoms
Hide Description 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.).
Time Frame Occurrence after randomization and until end of study participation (up to 12 mos.)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to long-acting injectable or oral risperidone
Arm/Group Title Long-acting Injectable Risperidone Oral Risperidone
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 40 43
Measure Type: Count of Participants
Unit of Measure: Participants
2
   5.0%
14
  32.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long-acting Injectable Risperidone, Oral Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.1
Estimation Comments [Not Specified]
3.Primary Outcome
Title Return to Work or School (SAS Work Section)
Hide Description 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.
Time Frame Measured from Baseline to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with data regarding return to work or school
Arm/Group Title Long-acting Injectable Risperidone Oral Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 37 38
Measure Type: Count of Participants
Unit of Measure: Participants
29
  78.4%
29
  76.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long-acting Injectable Risperidone, Oral Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .83
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Primary Outcome
Title Maintenance of Work/School Attendance (SAS)
Hide Description 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.
Time Frame Measured from Baseline to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with data on duration of work or school
Arm/Group Title Long-acting Injectable Risperidone Oral Risperidone
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 37 41
Mean (Standard Deviation)
Unit of Measure: weeks
26.7  (20.4) 21.1  (18.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long-acting Injectable Risperidone, Oral Risperidone
Comments A priori hypothesis was that long-acting injectible risperidone would lead to greater duration of work/school attendance than oral risperidone.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.20
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Primary Outcome
Title Global Functioning Scale: Role
Hide Description Change on a 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.
Time Frame Measured from Baseline to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Global Functioning Scale: Role ratings at baseline and 12 months
Arm/Group Title Long-acting Injectable Risperidone Oral Risperidone
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: Changes on a 10-point scale
1.5  (2.7) 1.2  (3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long-acting Injectable Risperidone, Oral Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .71
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score
Hide Description 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.
Time Frame Measured at baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with MCCB Overall Composite scores at baseline and 12 months
Arm/Group Title Long-acting Injectable Risperidone Oral Risperidone
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 32
Mean (Standard Deviation)
Unit of Measure: Changes in T scores
3.5  (7.5) 4.4  (5.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long-acting Injectable Risperidone, Oral Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.57
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Emotional Reactivity on Psychophysiological Measures
Hide Description 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.
Time Frame Measured from Baseline to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
No data were available because this part of the initial proposal was not funded.
Arm/Group Title Long-acting Injectable Risperidone Oral Risperidone
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Retention in Treatment
Hide Description 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.
Time Frame From baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to oral vs. long-acting injectable risperidone
Arm/Group Title Long-acting Injectable Risperidone Oral Risperidone
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 40 43
Mean (Standard Deviation)
Unit of Measure: days
307.6  (108.3) 270.7  (126.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long-acting Injectable Risperidone, Oral Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.16
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder-Revised (SUMD-R)
Hide Description 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.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with ratings at baseline and 12 months, with 6-month rating carried forward if no 12-month rating was completed.
Arm/Group Title Long-acting Injectable Risperidone Oral Risperidone
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 30 34
Mean (Standard Deviation)
Unit of Measure: Changes on a 4-point rating scale
.07  (1.34) -.24  (1.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long-acting Injectable Risperidone, Oral Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.41
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Long-acting Injectible Risperidone Oral Risperidone
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Long-acting Injectible Risperidone Oral Risperidone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Long-acting Injectible Risperidone Oral Risperidone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/40 (5.00%)      8/43 (18.60%)    
Psychiatric disorders     
psychiatric hospitalization  [1]  2/40 (5.00%)  2 8/43 (18.60%)  8
Indicates events were collected by systematic assessment
[1]
psychiatric hospitalization
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Long-acting Injectible Risperidone Oral Risperidone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/40 (27.50%)      19/43 (44.19%)    
Endocrine disorders     
Prolactin related * [1]  3/40 (7.50%)  3 4/43 (9.30%)  4
Metabolism and nutrition disorders     
BMI increase from normal or overweight to Obese  [2]  7/40 (17.50%)  7 5/43 (11.63%)  5
Nervous system disorders     
Tardive Dyskinesia  [3]  2/40 (5.00%)  2 3/43 (6.98%)  3
Vascular disorders     
Lipid Increase  [4]  2/40 (5.00%)  2 9/43 (20.93%)  9
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Symptoms related to prolactin levels
[2]
increase in BMI from normal or overweight to any Obese category
[3]
New onset of mild symptoms of Tardive Dyskinesia
[4]
Increase in LDL or Triglycerides from normal to high
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Keith Nuechterlein, PhD
Organization: University of California, Los Angeles
Phone: (310) 825-0036
EMail: keithn@ucla.edu
Layout table for additonal information
Responsible Party: Keith Nuechterlein, Ph.D., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00330551    
Other Study ID Numbers: P50MH066286 ( U.S. NIH Grant/Contract )
P50MH066286 ( U.S. NIH Grant/Contract )
DATR A2-AISZ ( Registry Identifier: World Health Organization ICTRP )
Janssen RIS-NAP-4009 ( Other Grant/Funding Number: Janssen Scientific Affairs )
First Submitted: May 26, 2006
First Posted: May 29, 2006
Results First Submitted: January 2, 2017
Results First Posted: March 23, 2020
Last Update Posted: March 23, 2020