SchizophreniaSATIETYNCT01269710

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

An observational study of Schizophrenia and Schizoaffective Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 3 to 19 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
How many people: 4 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Mar 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 19 years
All sexes
No healthy volunteers
Child, Adult

Study population: The investigators aim to recruit 200 individuals between the ages of 3 and 19, from a diverse range of ethnic and racial backgrounds, who have a clinical diagnosis of psychotic disorders, mood disorder or an autism spectrum disorder and are considered for treatment with second generation antipsychotic (SGAP) medication by a physician. Every effort will be made to recruit participants of all ethnicities, races and genders. The investigators will specifically target recruitment efforts toward minorities by using minority media and informational liaison with community organizations that serve minority populations.

Who may be able to join

Patients between the ages of 3 and 19 (at the time of consent)
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.
Subjects who are considered for treatment with second generation antipsychotics (SGAPs) by a physician who has evaluated him/her
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

Who cannot join

Individuals younger than 3 years or older than 19 years and 11 months (at the time of consent)
Personal history of or comorbid eating disorders
Active hyper-/hypothyroidism
Pregnancy
Severe medical disorder (i.e., AIDS, cancer, sepsis, etc.).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina
Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

Read the 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.

Conditions: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Psychotic Disorder, Not Otherwise Specified, Prodromal Schizophrenia, Mood Disorder
Keywords: Second Generation Antipsychotics, Schizophrenia, Schizoaffective, Schizophreniform, Psychosis NOS, Mood Disorders, Weight, Autism
Medical subject headings: Schizophrenia, Psychotic Disorders, Schizotypal Personality Disorder, Mood Disorders, Bipolar Disorder, Depressive Disorder, Major, Depressive Disorder, Autism Spectrum Disorder

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Weight (in Lbs.)
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.
Measured: Baseline and 52 Weeks

Secondary outcomes (4)

Change in Glucose Levels (mg/dL)
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.
Measured: Baseline and 52 Weeks
Change in Total Cholesterol (mg/dL)
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.
Measured: Baseline and 52 Weeks
Change in Triglycerides (mg/dL)
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.
Measured: Baseline and 52 Weeks
Change in LDL (mg/dL)
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.
Measured: Baseline and 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Mar 2011

First posted4 Jan 2011 (estimated)
Study startOct 2009
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01269710
Sponsor's protocol ID: 09-1734
Acronym: SATIETY
Status last verified: Jan 2013
First submitted: 3 Jan 2011
Last updated: 22 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study
ClinicalTrials.gov ID: NCT01269710
Acronym / sponsor ID: SATIETY / 09-1734
Conditions: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Psychotic Disorder, Not Otherwise Specified, Prodromal Schizophrenia, Mood Disorder
Keywords: Second Generation Antipsychotics, Schizophrenia, Schizoaffective, Schizophreniform, Psychosis NOS, Mood Disorders, Weight, Autism
Study type: Observational
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Study start: Oct 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 4 Jan 2011 (estimated)
Results: Posted 22 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 3 to 19 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: The investigators aim to recruit 200 individuals between the ages of 3 and 19, from a diverse range of ethnic and racial backgrounds, who have a clinical diagnosis of psychotic disorders, mood disorder or an autism spectrum disorder and are considered for treatment with second generation antipsychotic (SGAP) medication by a physician. Every effort will be made to recruit participants of all ethnicities, races and genders. The investigators will specifically target recruitment efforts toward minorities by using minority media and informational liaison with community organizations that serve minority populations.

Key inclusion criteria (4 listed)

Patients between the ages of 3 and 19 (at the time of consent)
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.
Subjects who are considered for treatment with second generation antipsychotics (SGAPs) by a physician who has evaluated him/her
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

Key exclusion criteria (5 listed)

Individuals younger than 3 years or older than 19 years and 11 months (at the time of consent)
Personal history of or comorbid eating disorders
Active hyper-/hypothyroidism
Pregnancy
Severe medical disorder (i.e., AIDS, cancer, sepsis, etc.).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change in Weight (in Lbs.)
Time frame: 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 secondary outcomes

Change in Glucose Levels (mg/dL)
Time frame: Baseline and 52 Weeks
Change in Total Cholesterol (mg/dL)
Time frame: Baseline and 52 Weeks
Change in Triglycerides (mg/dL)
Time frame: Baseline and 52 Weeks
Change in LDL (mg/dL)
Time frame: Baseline and 52 Weeks

Results and safety

Results posted to the registry on 22 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Observed Treatment Group	4	1

Primary outcome: Change in Weight (in Lbs.)

Time frame: Baseline and 52 Weeks. Mean (Standard Deviation). Unit: lbs.

Measure	Observed Treatment Group n = 4
Value	24.9 (20.09)

Population analysed: All four enrolled study participants were included in this analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observed Treatment Group	0 of 4 (0%)	0 of 4 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
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Healthy Adult Participants
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Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia and Schizoaffective Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight (in Lbs.) (time frame: Baseline and 52 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01269710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2013.