SchizophreniaNCT01222793
Effects of Antipsychotics on Eating and Food Craving in People With Schizophrenia
An observational study of Schizophrenia and Obesity, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: Although second-generation antipsychotic medications have fewer serious side effects and complications than first-generation ones, they are strongly associated with weight gain for reasons that are as yet unknown. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Obesity
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2010to 3 May 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants must:
- be between age 18 and 45.
- have a BMI between 25 or above.
- Participants in the antipsychotic-medication groups must:
- 1. meet DSM-IV criteria for schizophrenia or schizoaffective disorder, and have been stabilized on an antipsychotic medication for the past 3 months. Antipsychotics include olanzapine, clozapine, aripiprazole, ziprasidone, and first-generation antipsychotics (mid to high potency). Polypharmacy is allowed as long as both medications fit into the same grouping (HWGL or LWGL).
- Healthy controls must:
- 1. have no DSM IV Axis I disorder (Schizophrenia or schizoaffective disorder, Depression, Bipolar Disorder) based on a SCID interview.
Who cannot join
- Participants will be excluded if they:
- meet DSM-IV criteria for a past and/or current eating disorder via the SCID, or if they have a past medical history of an eating disorder, received treatment/counseling for an eating disorder and/or required hospitalization for an eating disorder. (If an otherwise undiagnosed eating disorder is detected during screening, referral to treatment will be provided.)
- are taking risperidone, quetiapine, paliperidone, iloperidone, or low-potency first-generation antipsychotics (see Appendix A for complete list of excluded medications).
- are taking weight-loss medications, whether over-the-counter (i.e. Hydroxycut, Stacker products, Metabo-Plus, CortiSlim), or prescribed, including appetite suppressants (Didrex, Tenuate, Sanorex, Mazanor, Adipex-P, Meridia, and Phentermine) and fat-absorption inhibitors (Xenical).
- are currently enrolled in a nutrition-based weight-loss program (i.e. Weight Watchers, Jenny Craig, Nutri-System).
- have undergone weight-loss surgery (i.e. banding, gastric bypass surgery, sleeve gastrectomy, liposuction).
Show all 15Show fewer
- have Cushing's syndrome, polycystic-ovary syndrome, hyperthyroidism, hypothyroidism, or a DSM-IV diagnosis of depression.
- have Type I or Type II diabetes, defined as a fasting blood glucose level of greater than or equal to 99.
- have cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires. This is defined an as a score of less than 10 on the Evaluation to Sign Consent (ESC) and judged by the treating clinician. Participants obtaining a 10 on the ESC are re-briefed on the item that they missed, and are asked the question again until they get it correct to ensure their understanding.
- have a medical illness that, in the view of the investigators, would compromise participation.
- have dietary restrictions or food allergies that, in the view of the investigators, would compromise participation.
- are pregnant (as this might alter appetite or cravings).
- have begun or stopped smoking in the previous 3 months
- Also, participants will be excluded from the control group if they:
- are taking antipsychotics, antidepressants or mood stabilizers.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201-1595
About this study
Background:
- Although second-generation antipsychotic medications have fewer serious side effects and complications than first-generation ones, they are strongly associated with weight gain for reasons that are as yet unknown. Comparing the effects of second-generation antipsychotics with a high weight-gain liability (HWGL) low weight-gain liability (LWGL) antipsychotics may provide more information on which medications are best suited for different individuals. Researchers are interested in studying how people taking various antipsychotics compare with controls in regard to food craving and eating behavior. This knowledge should help to guide practitioners when advising patients about the weight-gain effects of these medications.
Read more
Objectives:
- To examine eating behavior and food craving in patients with schizophrenia who are taking HWGL antipsychotics compared with those taking LWGL antipsychotics and with healthy controls taking no antipsychotics.
Eligibility:
- Individuals between 18 and 45 years of age who have been diagnosed with schizophrenia or a related disorder, have a body mass index between 25 and 29.9, and have never had an eating disorder.
- Healthy individuals between 18 and 45 years of age who have a body mass index between 25 and 29.9 and have never had an eating disorder.
Design:
- This study involves an initial screening visit and four study visits.
- Participants will be screened with a medical history and physical examination, as well as questionnaires about stress levels, food cravings, smoking, exercise, and eating habits; a taste test; and saliva collection (to measure stress hormones).
- Visit 2: Participants will have an optional overnight stay, and will provide blood samples before having a breakfast beverage and answering questions about tiredness, anxiety, hunger, and alertness during a 1.5 hour session.
Visit 3: Participants will have an optional overnight stay and a light breakfast, followed by blood draws and questions about hunger and food cravings.
Visit 4: Participants will have an optional overnight stay, followed by questions about food preference. Participants will not be allowed to eat until mid-morning of the next day.
Visit 5: Participants will eat normally before arriving at the research site, and will have tests to measure food craving and questionnaires about mood and feelings.
Read the detailed description
Objective
Some second-generation antipsychotics, such as olanzapine and clozapine, seem especially prone to induce metabolic complications and substantial increases in weight. The mechanisms of these side effects are unknown, but may include antagonism at histamine H1 receptors. We will refer to olanzapine and clozapine as antipsychotics with a high weight-gain liability (HWGL). The primary aim of this project is to examine eating and food craving in patients with schizophrenia who are taking HWGL antipsychotics compared with those taking LWGL antipsychotics (mid- to high-potency first-generation antipsychotics, aripiprazole, or ziparasidone) and compared with healthy controls taking no antipsychotics. The antipsychotics we are classifying as LWGL group do not have appreciable H1 receptor antagonism. We will exclude participants taking antipsychotics that have middling degrees of H1 receptor antagonism (e.g. quetiapine).
This study will help us understand how people with schizophrenia differ from controls on eating and food craving, as well as the effects of different classes of antipsychotics. This knowledge should help to guide practitioners when advising patients about the weight-gain effects of these medications. For example, if we find that participants on HWGL antipsychotics tend to crave high-fat foods, practitioners can work with patients to anticipate and mitigate this side effect.
Study population. The study population will be in- or outpatients with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder stabilized on either olanzapine or clozapine (HWGL antipsychotics) (N=20), aripiprazole, ziprasidone, or a first-generation antipsychotic (LWGL antipsychotics) (n=20), and normal controls (people with no Axis I psychiatric disorder taking no antipsychotic medication) (n=20), for a total of 60 participants. All participants will be between the ages of 18 to 45 years and considered overweight (BMI greater than or equal to 25 and less than or equal to 29.9 kg/m(SqrRoot)). The pediatric population has been excluded to rule out certain hormonal effects (e.g. puberty) on eating behavior. A BMI range encompassing participants that are overweight was selected to maximize recruitment and to minimize confounding effects of BMI on eating behavior. Exclusion criteria will include weight-related conditions and current dietary restrictions.
Experimental design and methods. In a between-subjects design, the three study groups will be compared in terms of four domains of eating behavior: (1) food craving, (2) satiety signaling, (3) meal size (satiation), and (4) food preferences. Assessments will occur during five study visits (including an initial visit for consenting and screening).
Outcome measures: Primary outcome measures will include a preload-test meal paradigm (satiety), meal size perception and satiation, food preference, food craving, and gustatory functioning. Secondary measures will include: Weight and Eating Assessment questionnaire, Recent Physical Activity Questionnaire (RPAQ), State Trait Anxiety Inventory (STAI), Exercise Motivations Inventory (EMI), Childhood Trauma Questionnaire, Tobacco Craving Questionnaire-Short Form (TCQ-SF), Fagerstrom Test for Nicotine Dependence (FTND), BMI, hip/waist measurements, and fasting blood work: CBC, CMP14, lipid panel, leptin, ghrelin, adiponectin, and thyroid panel.
- Conditions
- Schizophrenia, Obesity
- Keywords
- High Weight Gain Liability (HWLA), Antipsychotic, Obesity, Low Weight Gain, Schizophrenia, Food Craving
- Medical subject headings
- Schizophrenia, Obesity, Weight Gain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study start26 Sep 2010
- Study completion3 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Carol Myers, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222793
- Sponsor's protocol ID
- 999910460
- Other IDs
- 10-DA-N460
- Status last verified
- 3 May 2012
- First submitted
- 15 Oct 2010
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Addington D, Addington J, Maticka-Tyndale E. Assessing depression in schizophrenia: the Calgary Depression Scale. Br J Psychiatry Suppl. 1993 Dec;(22):39-44.
PubMed 8110442Andreasen NC. Negative symptoms in schizophrenia. Definition and reliability. Arch Gen Psychiatry. 1982 Jul;39(7):784-8. doi: 10.1001/archpsyc.1982.04290070020005.
PubMed 7165477Baptista T, De Mendoza S, Beaulieu S, Bermudez A, Martinez M. The metabolic syndrome during atypical antipsychotic drug treatment: mechanisms and management. Metab Syndr Relat Disord. 2004 Fall;2(4):290-307. doi: 10.1089/met.2004.2.290.
PubMed 18370698
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antipsychotics on Eating and Food Craving in People With Schizophrenia
- ClinicalTrials.gov ID
- NCT01222793
- Acronym / sponsor ID
- 999910460
- Conditions
- Schizophrenia, Obesity
- Keywords
- High Weight Gain Liability (HWLA), Antipsychotic, Obesity, Low Weight Gain, Schizophrenia, Food Craving
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 26 Sep 2010
- Study completion
- 3 May 2012
- First posted
- 18 Oct 2010 (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.
Background:
- Although second-generation antipsychotic medications have fewer serious side effects and complications than first-generation ones, they are strongly associated with weight gain for reasons that are as yet unknown. Comparing the effects of second-generation antipsychotics with a high weight-gain liability (HWGL) low weight-gain liability (LWGL) antipsychotics may provide more information on which medications are best suited for different individuals. Researchers are interested in studying how people taking various antipsychotics compare with controls in regard to food craving and eating behavior. This knowledge should help to guide practitioners when advising patients about the weight-gain effects of these medications.
Objectives:
- To examine eating behavior and food craving in patients with schizophrenia who are taking HWGL antipsychotics compared with those taking LWGL antipsychotics and with healthy controls taking no antipsychotics.
Eligibility:
- Individuals between 18 and 45 years of age who have been diagnosed with schizophrenia or a related disorder, have a body mass index between 25 and 29.9, and have never had an eating disorder.
- Healthy individuals between 18 and 45 years of age who have a body mass index between 25 and 29.9 and have never had an eating disorder.
Design:
- This study involves an initial screening visit and four study visits.
- Participants will be screened with a medical history and physical examination, as well as questionnaires about stress levels, food cravings, smoking, exercise, and eating habits; a taste test; and saliva collection (to measure stress hormones).
- Visit 2: Participants will have an optional overnight stay, and will provide blood samples before having a breakfast beverage and answering questions about tiredness, anxiety, hunger, and alertness during a 1.5 hour session.
Visit 3: Participants will have an optional overnight stay and a light breakfast, followed by blood draws and questions about hunger and food cravings.
Visit 4: Participants will have an optional overnight stay, followed by questions about food preference. Participants will not be allowed to eat until mid-morning of the next day.
Visit 5: Participants will eat normally before arriving at the research site, and will have tests to measure food craving and questionnaires about mood and feelings.
Detailed description
Objective
Some second-generation antipsychotics, such as olanzapine and clozapine, seem especially prone to induce metabolic complications and substantial increases in weight. The mechanisms of these side effects are unknown, but may include antagonism at histamine H1 receptors. We will refer to olanzapine and clozapine as antipsychotics with a high weight-gain liability (HWGL). The primary aim of this project is to examine eating and food craving in patients with schizophrenia who are taking HWGL antipsychotics compared with those taking LWGL antipsychotics (mid- to high-potency first-generation antipsychotics, aripiprazole, or ziparasidone) and compared with healthy controls taking no antipsychotics. The antipsychotics we are classifying as LWGL group do not have appreciable H1 receptor antagonism. We will exclude participants taking antipsychotics that have middling degrees of H1 receptor antagonism (e.g. quetiapine).
This study will help us understand how people with schizophrenia differ from controls on eating and food craving, as well as the effects of different classes of antipsychotics. This knowledge should help to guide practitioners when advising patients about the weight-gain effects of these medications. For example, if we find that participants on HWGL antipsychotics tend to crave high-fat foods, practitioners can work with patients to anticipate and mitigate this side effect.
Study population. The study population will be in- or outpatients with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder stabilized on either olanzapine or clozapine (HWGL antipsychotics) (N=20), aripiprazole, ziprasidone, or a first-generation antipsychotic (LWGL antipsychotics) (n=20), and normal controls (people with no Axis I psychiatric disorder taking no antipsychotic medication) (n=20), for a total of 60 participants. All participants will be between the ages of 18 to 45 years and considered overweight (BMI greater than or equal to 25 and less than or equal to 29.9 kg/m(SqrRoot)). The pediatric population has been excluded to rule out certain hormonal effects (e.g. puberty) on eating behavior. A BMI range encompassing participants that are overweight was selected to maximize recruitment and to minimize confounding effects of BMI on eating behavior. Exclusion criteria will include weight-related conditions and current dietary restrictions.
Experimental design and methods. In a between-subjects design, the three study groups will be compared in terms of four domains of eating behavior: (1) food craving, (2) satiety signaling, (3) meal size (satiation), and (4) food preferences. Assessments will occur during five study visits (including an initial visit for consenting and screening).
Outcome measures: Primary outcome measures will include a preload-test meal paradigm (satiety), meal size perception and satiation, food preference, food craving, and gustatory functioning. Secondary measures will include: Weight and Eating Assessment questionnaire, Recent Physical Activity Questionnaire (RPAQ), State Trait Anxiety Inventory (STAI), Exercise Motivations Inventory (EMI), Childhood Trauma Questionnaire, Tobacco Craving Questionnaire-Short Form (TCQ-SF), Fagerstrom Test for Nicotine Dependence (FTND), BMI, hip/waist measurements, and fasting blood work: CBC, CMP14, lipid panel, leptin, ghrelin, adiponectin, and thyroid panel.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- be between age 18 and 45.
- have a BMI between 25 or above.
- 1. meet DSM-IV criteria for schizophrenia or schizoaffective disorder, and have been stabilized on an antipsychotic medication for the past 3 months. Antipsychotics include olanzapine, clozapine, aripiprazole, ziprasidone, and first-generation antipsychotics (mid to high potency). Polypharmacy is allowed as long as both medications fit into the same grouping (HWGL or LWGL).
- 1. have no DSM IV Axis I disorder (Schizophrenia or schizoaffective disorder, Depression, Bipolar Disorder) based on a SCID interview.
Key exclusion criteria (15 listed)
- meet DSM-IV criteria for a past and/or current eating disorder via the SCID, or if they have a past medical history of an eating disorder, received treatment/counseling for an eating disorder and/or required hospitalization for an eating disorder. (If an otherwise undiagnosed eating disorder is detected during screening, referral to treatment will be provided.)
- are taking risperidone, quetiapine, paliperidone, iloperidone, or low-potency first-generation antipsychotics (see Appendix A for complete list of excluded medications).
- are taking weight-loss medications, whether over-the-counter (i.e. Hydroxycut, Stacker products, Metabo-Plus, CortiSlim), or prescribed, including appetite suppressants (Didrex, Tenuate, Sanorex, Mazanor, Adipex-P, Meridia, and Phentermine) and fat-absorption inhibitors (Xenical).
- are currently enrolled in a nutrition-based weight-loss program (i.e. Weight Watchers, Jenny Craig, Nutri-System).
- have undergone weight-loss surgery (i.e. banding, gastric bypass surgery, sleeve gastrectomy, liposuction).
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
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 8110442Addington D, Addington J, Maticka-Tyndale E. Assessing depression in schizophrenia: the Calgary Depression Scale. Br J Psychiatry Suppl. 1993 Dec;(22):39-44.
- Background: PubMed 7165477Andreasen NC. Negative symptoms in schizophrenia. Definition and reliability. Arch Gen Psychiatry. 1982 Jul;39(7):784-8. doi: 10.1001/archpsyc.1982.04290070020005.
- Background: PubMed 18370698Baptista T, De Mendoza S, Beaulieu S, Bermudez A, Martinez M. The metabolic syndrome during atypical antipsychotic drug treatment: mechanisms and management. Metab Syndr Relat Disord. 2004 Fall;2(4):290-307. doi: 10.1089/met.2004.2.290.
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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.
Carol Myers, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
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 Obesity, run by National Institute on Drug Abuse (NIDA) 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 7 inclusion and 15 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01222793, which also lists 3 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 2 Jul 2017.