Trial Outcomes & Findings for Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study (NCT NCT01269710)
NCT ID: NCT01269710
Last Updated: 2013-02-22
Results Overview
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52). Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.
COMPLETED
4 participants
Baseline and 52 Weeks
2013-02-22
Participant Flow
Subjects will be recruited from outpatient child psychiatry programs (including community clinics, school based mental health programs, private practices), inpatient psychiatry units and community outreach efforts.
Treatment of subjects enrolled in this study will be determined by their clinician and will remain unaffected by participation in this observational minimal risk study.
Participant milestones
| Measure |
Observed Treatment Group
Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks.
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|---|---|
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Overall Study
STARTED
|
4
|
|
Overall Study
Week 12
|
3
|
|
Overall Study
Week 36
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study
Baseline characteristics by cohort
| Measure |
Observed Treatment Group
n=4 Participants
Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks.
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|---|---|
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Age, Categorical
<=18 years
|
3 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and 52 WeeksPopulation: All four enrolled study participants were included in this analysis.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52). Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.
Outcome measures
| Measure |
Observed Treatment Group
n=4 Participants
Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks.
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|---|---|
|
Change in Weight (in Lbs.)
|
24.9 lbs.
Standard Deviation 20.09
|
SECONDARY outcome
Timeframe: Baseline and 52 WeeksPopulation: All four enrolled study participants were included in this analysis.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52). Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.
Outcome measures
| Measure |
Observed Treatment Group
n=4 Participants
Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks.
|
|---|---|
|
Change in Glucose Levels (mg/dL)
|
-2.25 mg/dL
Standard Deviation 5.38
|
SECONDARY outcome
Timeframe: Baseline and 52 WeeksPopulation: All four enrolled study participants were included in this analysis.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52). Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.
Outcome measures
| Measure |
Observed Treatment Group
n=4 Participants
Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks.
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|---|---|
|
Change in Total Cholesterol (mg/dL)
|
-8.75 mg/dL
Standard Deviation 12.61
|
SECONDARY outcome
Timeframe: Baseline and 52 WeeksPopulation: All four enrolled study participants were included in this analysis.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52). Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.
Outcome measures
| Measure |
Observed Treatment Group
n=4 Participants
Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks.
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|---|---|
|
Change in Triglycerides (mg/dL)
|
18.75 mg/dL
Standard Deviation 61.15
|
SECONDARY outcome
Timeframe: Baseline and 52 WeeksPopulation: All four enrolled study participants were included in this analysis.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52). Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.
Outcome measures
| Measure |
Observed Treatment Group
n=4 Participants
Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks.
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|---|---|
|
Change in LDL (mg/dL)
|
-6.25 mg/dL
Standard Deviation 4.57
|
Adverse Events
Observed Treatment Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Linmarie Sikich, M.D.
The University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place