SATIETY: Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT01269710
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Duration (Months): 17
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to get a better understanding of the side effect burden and identify predictors of psychotic, mood and aggressive disorders in children and adolescents. The study's primary aim is to identify genetic risk factors for weight gain and metabolic abnormalities.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorder, Not Otherwise Specified; Prodromal Schizophrenia; Mood Disorder; Bipolar Disorder; Major Depressive Disorder; Depressive Disorder, Not Otherwise Specified; Mood Disorder, Not Otherwise Specified; Autism Spectrum Disorder

Detailed Description

Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAPs (second generation antipsychotics) during 4 visits over 12 weeks. Participants will also be evaluated at month 6, 9, and 12. This study does not involve treatment for participants. 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.

All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25mg to 6mg daily for 52 weeks.

Study Design

• Study Type: Observational
• Actual Enrollment: 4 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Outcome Measures

Primary Outcome Measures

1. Change in Weight (in Lbs.) [Baseline and 52 Weeks]

   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.

Secondary Outcome Measures

1. Change in Glucose Levels (mg/dL) [Baseline and 52 Weeks]

   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.

2. Change in Total Cholesterol (mg/dL) [Baseline and 52 Weeks]

   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.

3. Change in Triglycerides (mg/dL) [Baseline and 52 Weeks]

   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.

4. Change in LDL (mg/dL) [Baseline and 52 Weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients between the ages of 3 and 19 (at the time of consent)

2. Clinical diagnosis of psychotic disorders (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified and prodromal schizophrenia (as defined by the Scale of Prodromal Symptoms (SOPS: Miller 1996)), mood disorder (i.e., bipolar disorder, major depressive disorder, depressive disorder not otherwise specified, mood disorder not otherwise specified) or an autism spectrum disorder.

3. Subjects who are considered for treatment with second generation antipsychotics (SGAPs) by a physician who has evaluated him/her

4. Subjects who are either A) antipsychotic naïve and have started an SGA within the past 2 weeks , B) have started a new antipsychotic within the past 2 weeks (specifically within 2 weeks of their first blood draw), or

Exclusion Criteria:

1. Individuals younger than 3 years or older than 19 years and 11 months (at the time of consent)

2. Personal history of or comorbid eating disorders

3. Active hyper-/hypothyroidism

4. Pregnancy

5. Severe medical disorder (i.e., AIDS, cancer, sepsis, etc.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina	Chapel Hill	North Carolina	United States	27514

Sponsors and Collaborators

• University of North Carolina, Chapel Hill

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Linmarie Sikich, MD, Associate Professor of Psychiatry, University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT01269710
• Other Study ID Numbers: 09-1734
• First Posted: Jan 4, 2011
• Last Update Posted: Feb 22, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Linmarie Sikich, MD, Associate Professor of Psychiatry, University of North Carolina, Chapel Hill: Second Generation Antipsychotics; Schizophrenia; Schizoaffective; Schizophreniform; Psychosis NOS; Mood Disorders; Weight; Autism
• Additional relevant MeSH terms: Disease; Schizophrenia; Depressive Disorder; Depression; Depressive Disorder, Major; Bipolar Disorder; Autism Spectrum Disorder; Psychotic Disorders; Mood Disorders

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Observed Treatment Group
Arm/Group Description	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.
Period Title: Overall Study
STARTED	4
Week 12	3
Week 36	2
COMPLETED	1
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Observed Treatment Group
Arm/Group Description	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.
Overall Participants	4
Age (Count of Participants)
<=18 years	3 75%
Between 18 and 65 years	1 25%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	2 50%
Male	2 50%

Outcome Measures

1. Primary Outcome

Title	Change in Weight (in Lbs.)
Description	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.
Time Frame	Baseline and 52 Weeks

Outcome Measure Data

Analysis Population Description

All four enrolled study participants were included in this analysis.

Arm/Group Title	Observed Treatment Group
Arm/Group Description	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.
Measure Participants	4
Mean (Standard Deviation) [lbs.]	24.9 (20.09)

2. Secondary Outcome

Title	Change in Glucose Levels (mg/dL)
Description	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.
Time Frame	Baseline and 52 Weeks

Outcome Measure Data

Analysis Population Description

All four enrolled study participants were included in this analysis.

Arm/Group Title	Observed Treatment Group
Arm/Group Description	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.
Measure Participants	4
Mean (Standard Deviation) [mg/dL]	-2.25 (5.38)

3. Secondary Outcome

Title	Change in Total Cholesterol (mg/dL)
Description	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.
Time Frame	Baseline and 52 Weeks

Outcome Measure Data

Analysis Population Description

All four enrolled study participants were included in this analysis.

Arm/Group Title	Observed Treatment Group
Arm/Group Description	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.
Measure Participants	4
Mean (Standard Deviation) [mg/dL]	-8.75 (12.61)

4. Secondary Outcome

Title	Change in Triglycerides (mg/dL)
Description	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.
Time Frame	Baseline and 52 Weeks

Outcome Measure Data

Analysis Population Description

All four enrolled study participants were included in this analysis.

Arm/Group Title	Observed Treatment Group
Arm/Group Description	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.
Measure Participants	4
Mean (Standard Deviation) [mg/dL]	18.75 (61.15)

5. Secondary Outcome

Title	Change in LDL (mg/dL)
Description	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.
Time Frame	Baseline and 52 Weeks

Outcome Measure Data

Analysis Population Description

All four enrolled study participants were included in this analysis.

Arm/Group Title	Observed Treatment Group
Arm/Group Description	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.
Measure Participants	4
Mean (Standard Deviation) [mg/dL]	-6.25 (4.57)

Adverse Events

Arm/Group Title	Observed Treatment Group
Arm/Group Description	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.
All Cause Mortality
	Observed Treatment Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Observed Treatment Group
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Other (Not Including Serious) Adverse Events
	Observed Treatment Group
	Affected / at Risk (%)	# Events
Total	0/4 (0%)

Limitations/Caveats

This study only enrolled 4 subjects, thus, sample size was a significant limitation. Further, since only a single subject completed to Week 52, it is difficult to determine treatment indication effectiveness with second generation antipsychotics.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.