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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01269710
First received: January 3, 2011
Last updated: January 18, 2013
Last verified: January 2013
Results First Received: November 8, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Observed Treatment Group  
STARTED     4  
Week 12     3  
Week 36     2  
COMPLETED     1 [1]
NOT COMPLETED     3  
[1] This refers to Week 52.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Baseline Measures
    Observed Treatment Group  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     3  
Between 18 and 65 years     1  
>=65 years     0  
Gender  
[units: participants]
 
Female     2  
Male     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Weight (in Lbs.)   [ Time Frame: Baseline and 52 Weeks ]

2.  Secondary:   Change in Glucose Levels (mg/dL)   [ Time Frame: Baseline and 52 Weeks ]

3.  Secondary:   Change in Total Cholesterol (mg/dL)   [ Time Frame: Baseline and 52 Weeks ]

4.  Secondary:   Change in Triglycerides (mg/dL)   [ Time Frame: Baseline and 52 Weeks ]

5.  Secondary:   Change in LDL (mg/dL)   [ Time Frame: Baseline and 52 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Linmarie Sikich, M.D.
Organization: The University of North Carolina at Chapel Hill
phone: (919) 972-7499
e-mail: lsikich@med.unc.edu


No publications provided


Responsible Party: Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01269710     History of Changes
Other Study ID Numbers: 09-1734
Study First Received: January 3, 2011
Results First Received: November 8, 2012
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board