Psychotic DisordersADAPTNCT00903916
Effect of Antipsychotics on Appetite Regulation
An observational study of Psychotic Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to evaluate changes in appetite-regulating hormones, body composition (weight, body fat%), and hunger ratings in persons early in treatment with one of four atypical antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Psychotic Disorders
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients ages 18 to 40 years of age who are early in treatment (i.e., started treatment in the past month) with 1 of 4 antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole)
Who may be able to join
- Meets DSM IV criteria for a psychotic disorder (schizophrenia, schizophreniform, brief psychotic disorder, schizoaffective disorder), bipolar disorder, or major depression with psychotic features;
- "Drug naïve" prior to most recent psychiatric diagnosis;
- Currently prescribed one of four atypical antipsychotic medications: olanzapine, risperidone, ziprasidone, or aripiprazole;
- Between the ages of 18 and 40, any race and either gender;
- Not obese (BMI < 30 kg/m2) (fasting and postprandial ghrelin levels are altered in obesity);
- Has negative histories for cardiovascular, metabolic, and endocrine disorders at screening;
- Is willing and able to eat animal-derived foods; and
- Is not exercising 3 or more times per week.
Who cannot join
- Use of medications to treat metabolic and endocrine abnormalities, corticosteroids, over-the-counter appetite suppressants that contain phentermine or Sibutramine;
- Active involvement with a weight loss program (i.e., Weight Watchers);
- Serious or unstable medical illness which requires ongoing treatment with medication (this does not include hypertension);
- Anemia;
- At serious suicidal risk;
- Current substance abuse or dependence;
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- For female subjects, pregnancy or nursing (because pregnancy may influence appetite and because the body composition procedure involves low level X-ray exposure).
- Known history of mental retardation or dementia.
- Children and adolescents under age 18 will be excluded owing to the inherent confounding effects of normal growth on body weight and appetite.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Effect of Weight-increasing Psychotropic Medications on Appetite Regulation
The purpose of this study is to evaluate changes in appetite-regulating hormones, body composition (weight, body fat%), and hunger ratings in persons early in treatment with one of four atypical antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole).
Read the detailed description
Severe weight gain and glucose dysregulation are serious problems in patients treated with second-generation ('atypical') antipsychotics (SGA). These side effects frequently interfere with medication compliance and necessitate discontinuation of treatment. Although the causal mechanisms for weight and glucose dysregulation are not well understood, one promising area of investigation targets SGA-induced disturbances in appetite and in appetite-regulating hormones. Findings from our group (and others) demonstrate SGA treatment-related increases in fasting levels of the appetite-stimulating hormone, ghrelin, as well as increases in self-report hunger. This novel study will examine prospective changes in ghrelin and in the 'satiety-signaling' peptide YY (PYY) as measured before and after participants consume a standard mixed-macronutrient meal. Data are obtained at baseline (within 4 weeks of beginning medication), and again 2 months and 4 months later.
- Conditions
- Psychotic Disorders
- Keywords
- antipsychotic, ghrelin, PYY, appetite, weight gain
- Medical subject headings
- Psychotic Disorders, Weight Gain
What is being measured
The primary outcome is the main question the study is designed to answer.
ghrelin area under the curve
Measured: baseline, 2 and 4 months
PYY area under the curve
Measured: baseline, 2 and 4 months
Secondary outcomes (4)
glucose area under the curve
Measured: baseline, 2 and 4 months
insulin area under the curve
Measured: baseline, 2 and 4 months
body composition
Measured: baseline, 2 and 4 months
subjective appetite ratings
Measured: baseline, 2 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startAug 2007
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kimberly Brownley, University of North Carolina, Chapel Hill
- Investigators
- Kimberly A Brownley, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903916
- Sponsor's protocol ID
- 3024-04003
- Other IDs
- 1R01MH077117-01A2
- Acronym
- ADAPT
- Status last verified
- Apr 2012
- First submitted
- 17 May 2009
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Graham KA, Cho H, Brownley KA, Harp JB. Early treatment-related changes in diabetes and cardiovascular disease risk markers in first episode psychosis subjects. Schizophr Res. 2008 Apr;101(1-3):287-94. doi: 10.1016/j.schres.2007.12.476. Epub 2008 Feb 5.
PubMed 18255275Graham KA, Perkins DO, Edwards LJ, Barrier RC Jr, Lieberman JA, Harp JB. Effect of olanzapine on body composition and energy expenditure in adults with first-episode psychosis. Am J Psychiatry. 2005 Jan;162(1):118-23. doi: 10.1176/appi.ajp.162.1.118.
PubMed 15625209
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight-increasing Psychotropic Medications on Appetite Regulation
- ClinicalTrials.gov ID
- NCT00903916
- Acronym / sponsor ID
- ADAPT / 3024-04003
- Conditions
- Psychotic Disorders
- Keywords
- antipsychotic, ghrelin, PYY, appetite, weight gain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate changes in appetite-regulating hormones, body composition (weight, body fat%), and hunger ratings in persons early in treatment with one of four atypical antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole).
Detailed description
Severe weight gain and glucose dysregulation are serious problems in patients treated with second-generation ('atypical') antipsychotics (SGA). These side effects frequently interfere with medication compliance and necessitate discontinuation of treatment. Although the causal mechanisms for weight and glucose dysregulation are not well understood, one promising area of investigation targets SGA-induced disturbances in appetite and in appetite-regulating hormones. Findings from our group (and others) demonstrate SGA treatment-related increases in fasting levels of the appetite-stimulating hormone, ghrelin, as well as increases in self-report hunger. This novel study will examine prospective changes in ghrelin and in the 'satiety-signaling' peptide YY (PYY) as measured before and after participants consume a standard mixed-macronutrient meal. Data are obtained at baseline (within 4 weeks of beginning medication), and again 2 months and 4 months later.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients ages 18 to 40 years of age who are early in treatment (i.e., started treatment in the past month) with 1 of 4 antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole)
Key inclusion criteria (8 listed)
- Meets DSM IV criteria for a psychotic disorder (schizophrenia, schizophreniform, brief psychotic disorder, schizoaffective disorder), bipolar disorder, or major depression with psychotic features;
- "Drug naïve" prior to most recent psychiatric diagnosis;
- Currently prescribed one of four atypical antipsychotic medications: olanzapine, risperidone, ziprasidone, or aripiprazole;
- Between the ages of 18 and 40, any race and either gender;
- Not obese (BMI < 30 kg/m2) (fasting and postprandial ghrelin levels are altered in obesity);
Key exclusion criteria (9 listed)
- Use of medications to treat metabolic and endocrine abnormalities, corticosteroids, over-the-counter appetite suppressants that contain phentermine or Sibutramine;
- Active involvement with a weight loss program (i.e., Weight Watchers);
- Serious or unstable medical illness which requires ongoing treatment with medication (this does not include hypertension);
- Anemia;
- At serious suicidal risk;
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
ghrelin area under the curve
Time frame: baseline, 2 and 4 months
PYY area under the curve
Time frame: baseline, 2 and 4 months
4 secondary outcomes
glucose area under the curve
Time frame: baseline, 2 and 4 months
insulin area under the curve
Time frame: baseline, 2 and 4 months
body composition
Time frame: baseline, 2 and 4 months
subjective appetite ratings
Time frame: baseline, 2 and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
- Background: PubMed 18255275Graham KA, Cho H, Brownley KA, Harp JB. Early treatment-related changes in diabetes and cardiovascular disease risk markers in first episode psychosis subjects. Schizophr Res. 2008 Apr;101(1-3):287-94. doi: 10.1016/j.schres.2007.12.476. Epub 2008 Feb 5.
- Background: PubMed 15625209Graham KA, Perkins DO, Edwards LJ, Barrier RC Jr, Lieberman JA, Harp JB. Effect of olanzapine on body composition and energy expenditure in adults with first-episode psychosis. Am J Psychiatry. 2005 Jan;162(1):118-23. doi: 10.1176/appi.ajp.162.1.118.
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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.
Kimberly A Brownley, PhD principal investigator
University of North Carolina, Chapel Hill
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 Psychotic Disorders, 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 8 inclusion and 9 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 3 Apr 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ghrelin area under the curve (time frame: baseline, 2 and 4 months). The study lists 2 primary outcomes in all. 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 NCT00903916, which also lists 2 linked publications.
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 3 Apr 2012.