Trial Outcomes & Findings for High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone (NCT NCT00539071)
NCT ID: NCT00539071
Last Updated: 2025-10-01
Results Overview
The mean (SEM) of Positive and Negative Syndrome Scale (PANSS) The Positive and Negative Syndrome Scale (PANSS) is a 30-item questionnaire used to assess the severity of symptoms in schizophrenia. It's considered a gold standard for measuring symptom change in antipsychotic trials and other research. The PANSS is divided into three subscales: positive symptoms, negative symptoms, and general psychopathology. Each item is rated on a 7-point scale, ranging from absent to extreme. Therefore, the minimum possible score of 0 and maximum possible score is 210, but those scores may never be seen in a practical setting. If the score reduces over time that indicates improvement of the symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
160 participants
Primary outcome timeframe
six months
Results posted on
2025-10-01
Participant Flow
One hundred sixty-nine patients who met Diagnostic and Statistical Manual (DSM-IV) criteria for schizophrenia or schizoaffective disorder were screened, and 160 patients were enrolled.
Participant milestones
| Measure |
Conventional Dose
All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).
Subjects will be randomized to conventional dose Consta or high dose Consta. All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks.
|
High Dose Group
Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent.
Those who are randomized to high-dose Consta will receive a Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
78
|
|
Overall Study
COMPLETED
|
59
|
55
|
|
Overall Study
NOT COMPLETED
|
23
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone
Baseline characteristics by cohort
| Measure |
Conventional Dose
n=82 Participants
All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).
long-acting injectable risperidone, Conventional Dose Group: The study dose remains 50 mg for the length of the study.
|
High Dose Group
n=78 Participants
Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent.
long-acting injectable risperidone, High Dose Group: Beginning dose 75 mg. Can be increased to 100 mg at Week 6.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
82 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
160 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
|
39.2 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
41 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
40.1 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
148 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
|
|
Region of Enrollment
United States
|
82 participants
n=5 Participants
|
78 participants
n=7 Participants
|
160 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: six monthsPopulation: patients who met DSM-IV criteria for schizophrenia or schizoaffective disorder
The mean (SEM) of Positive and Negative Syndrome Scale (PANSS) The Positive and Negative Syndrome Scale (PANSS) is a 30-item questionnaire used to assess the severity of symptoms in schizophrenia. It's considered a gold standard for measuring symptom change in antipsychotic trials and other research. The PANSS is divided into three subscales: positive symptoms, negative symptoms, and general psychopathology. Each item is rated on a 7-point scale, ranging from absent to extreme. Therefore, the minimum possible score of 0 and maximum possible score is 210, but those scores may never be seen in a practical setting. If the score reduces over time that indicates improvement of the symptoms.
Outcome measures
| Measure |
Conventional Dose
n=82 Participants
All of those who are randomized to the conventional Consta dose will receive a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 3 unless symptoms warrant a quicker titration) along with the injections. Oral risperidone will be discontinued after Week 4. At Week 6, psychopathology will be assessed with PANSS. Dose will remain at 50 mg q 2 weeks for those in the conventional Consta dose group.
|
High Dose Group
n=78 Participants
Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent. As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 4 unless symptoms warrant a quicker titration) along with the injections. Any oral risperidone the patients receive will be discontinued after Week 4. Psychopathology will be assessed with a PANSS at Week 6. If no improvement since baseline, dose will be increased to two 50 mg injections q 2 weeks for the remainder of the study.
|
|---|---|---|
|
Total Positive and Negative Syndrome Scale (PANSS) Score Between Baseline and 24 Weeks.
Baseline
|
89.0 score on a scale
Standard Error 1.2
|
89.7 score on a scale
Standard Error 1.3
|
|
Total Positive and Negative Syndrome Scale (PANSS) Score Between Baseline and 24 Weeks.
6 Weeks
|
80.0 score on a scale
Standard Error 1.3
|
80.8 score on a scale
Standard Error 1.3
|
|
Total Positive and Negative Syndrome Scale (PANSS) Score Between Baseline and 24 Weeks.
12 Weeks
|
74.2 score on a scale
Standard Error 1.3
|
78.0 score on a scale
Standard Error 1.4
|
|
Total Positive and Negative Syndrome Scale (PANSS) Score Between Baseline and 24 Weeks.
18 Weeks
|
72.3 score on a scale
Standard Error 1.4
|
74.0 score on a scale
Standard Error 1.4
|
|
Total Positive and Negative Syndrome Scale (PANSS) Score Between Baseline and 24 Weeks.
24 Weeks
|
70.9 score on a scale
Standard Error 1.4
|
72.0 score on a scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: six monthsPopulation: patients who met DSM-IV criteria for schizophrenia or schizoaffective disorder
Positive and Negative Syndrome Scale (PANSS) Positive scale: Consists of sum of 7 items, so the score can range from 0 - 49. Improvement means lower scores over time
Outcome measures
| Measure |
Conventional Dose
n=82 Participants
All of those who are randomized to the conventional Consta dose will receive a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 3 unless symptoms warrant a quicker titration) along with the injections. Oral risperidone will be discontinued after Week 4. At Week 6, psychopathology will be assessed with PANSS. Dose will remain at 50 mg q 2 weeks for those in the conventional Consta dose group.
|
High Dose Group
n=78 Participants
Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent. As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 4 unless symptoms warrant a quicker titration) along with the injections. Any oral risperidone the patients receive will be discontinued after Week 4. Psychopathology will be assessed with a PANSS at Week 6. If no improvement since baseline, dose will be increased to two 50 mg injections q 2 weeks for the remainder of the study.
|
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Positive Scale
PANSS Positive Baseline
|
24.0 score on a scale
Standard Error 0.4
|
24.2 score on a scale
Standard Error 0.5
|
|
Positive and Negative Syndrome Scale (PANSS) Positive Scale
PANSS Positive 6 Weeks
|
20.8 score on a scale
Standard Error 0.5
|
21.4 score on a scale
Standard Error 0.5
|
|
Positive and Negative Syndrome Scale (PANSS) Positive Scale
PANSS Positive 12 Weeks
|
20.0 score on a scale
Standard Error 0.5
|
20.0 score on a scale
Standard Error 0.5
|
|
Positive and Negative Syndrome Scale (PANSS) Positive Scale
PANSS Positive 18 Weeks
|
18.2 score on a scale
Standard Error 0.5
|
19.1 score on a scale
Standard Error 0.5
|
|
Positive and Negative Syndrome Scale (PANSS) Positive Scale
PANSS Positive 24 Weeks
|
18.1 score on a scale
Standard Error 0.5
|
18.1 score on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: six monthsPopulation: patients who met DSM-IV criteria for schizophrenia or schizoaffective disorder
Positive and Negative Syndrome Scale (PANSS) Negative scale: Consists of sum of 7 items, so the score can range from 0 - 49. Improvement means lower scores over time
Outcome measures
| Measure |
Conventional Dose
n=82 Participants
All of those who are randomized to the conventional Consta dose will receive a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 3 unless symptoms warrant a quicker titration) along with the injections. Oral risperidone will be discontinued after Week 4. At Week 6, psychopathology will be assessed with PANSS. Dose will remain at 50 mg q 2 weeks for those in the conventional Consta dose group.
|
High Dose Group
n=78 Participants
Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent. As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 4 unless symptoms warrant a quicker titration) along with the injections. Any oral risperidone the patients receive will be discontinued after Week 4. Psychopathology will be assessed with a PANSS at Week 6. If no improvement since baseline, dose will be increased to two 50 mg injections q 2 weeks for the remainder of the study.
|
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Negative Scale
PANSS Negative Baseline
|
21.0 score on a scale
Standard Error 0.4
|
21.2 score on a scale
Standard Error 0.4
|
|
Positive and Negative Syndrome Scale (PANSS) Negative Scale
PANSS Negative 6 Weeks
|
19.8 score on a scale
Standard Error 0.4
|
19.5 score on a scale
Standard Error 0.4
|
|
Positive and Negative Syndrome Scale (PANSS) Negative Scale
PANSS Negative 12 Weeks
|
18.4 score on a scale
Standard Error 0.4
|
19.2 score on a scale
Standard Error 0.5
|
|
Positive and Negative Syndrome Scale (PANSS) Negative Scale
PANSS Negative 18 Weeks
|
17.9 score on a scale
Standard Error 0.4
|
18.6 score on a scale
Standard Error 0.4
|
|
Positive and Negative Syndrome Scale (PANSS) Negative Scale
PANSS Negative 24 Weeks
|
17.9 score on a scale
Standard Error 0.4
|
18.5 score on a scale
Standard Error 0.5
|
Adverse Events
Conventional Dose
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
High Dose Group
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conventional Dose
n=82 participants at risk
All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 3 unless symptoms warrant a quicker titration) along with the injections.
|
High Dose Group
n=78 participants at risk
Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent. As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 4 unless symptoms warrant a quicker titration) along with the injections.
|
|---|---|---|
|
Nervous system disorders
Extrapyramidal
|
2.4%
2/82 • Number of events 2 • 6 months
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
6.4%
5/78 • Number of events 5 • 6 months
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
Other adverse events
| Measure |
Conventional Dose
n=82 participants at risk
All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 3 unless symptoms warrant a quicker titration) along with the injections.
|
High Dose Group
n=78 participants at risk
Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent. As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 4 unless symptoms warrant a quicker titration) along with the injections.
|
|---|---|---|
|
General disorders
Non-Serious Adverse Events
|
17.1%
14/82 • Number of events 19 • 6 months
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
16.7%
13/78 • Number of events 19 • 6 months
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place