SchizophreniaNCT07411222
Emotional Eating, Sleep Quality, Mental State and Metabolic Syndrome
An observational study of Schizophrenia and Bipolar Disorder, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
In predominantly medication-naïve schizophrenic patients, those exhibiting partial metabolic disorders have significantly worse sleep quality and sleep onset time; poor sleep predicted metabolic dysregulation even after controlling for confounding factors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Psychiatric Issue
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals being followed at the Community Mental Health Center, diagnosed with schizophrenia or bipolar disorder, who volunteered to participate in the study and were able to provide written consent.
Who may be able to join
- Being registered with the Bolu İzzet Baysal Mental Health and Diseases Hospital Community Mental Health Center,
- Having a severe chronic psychiatric illness (Schizophrenia Spectrum and Other Psychotic Disorders and Bipolar Disorder) followed by the Bolu İzzet Baysal Mental Health and Diseases Hospital Community Mental Health Center for at least 6 months,
- Being in remission (Complete Remission (Pre-Remission): Symptoms remaining below threshold values for at least 2 months (8 weeks). A state of improvement lasting more than 2 months is generally referred to as "remission"),
- Schizophrenia remission definition: 8 diagnostically significant symptoms were selected from the Positive and Negative Syndrome Scale.
- Bipolar disorder remission definition: Complete remission is defined as the absence of acute attacks and the presence of minimal/very mild symptoms.
- Being between 18-65 years of age,
- Being able to understand what is read and give written consent.
Who cannot join
- Having a diagnosis of mental retardation,
- Having other neurocognitive disorders, primarily dementia, according to DSM-V (as it can affect the ability to make decisions and give correct answers),
- Not being able to speak or understand Turkish.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nur Özgedik Turhan, Psychiatrist contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Melisa Bulut
Bolu, Bolu, 141000
Melisa Bulut, PhD, melisaaabulut@gmail.com
Nur Özgedik Turhan, psychiatrist
About this study
Official title: The Mediating Role of Emotional Eating and Sleep Quality in the Relationship Between Mental State and Metabolic Syndrome in Individuals With Schizophrenia and Bipolar Disorder
In predominantly medication-naïve schizophrenic patients, those exhibiting partial metabolic disorders have significantly worse sleep quality and sleep onset time; poor sleep predicted metabolic dysregulation even after controlling for confounding factors. Mental health, sleep, and eating behavior interact in ways that strongly influence the risk of obesity and MetS. Emotional eating (eating in response to emotions rather than hunger) is central to this network and appears to be closely associated with psychiatric illnesses, particularly depression, anxiety, and sleep disorders. There is a continuing need to elucidate the frequency, level, and relationship of emotional eating with other factors in individuals with SMI. Therefore, this study aims to elucidate this complex relationship, thereby shedding light on new ways to reduce metabolic risks in psychiatric patients.
Read the detailed description
Research Questions
- Is there a relationship between mental status and MetS in individuals with SMI?
- How does diagnosis (schizophrenia or bipolar disorder) and the group of medications used affect MetS in individuals with SMI?
- What is the level of emotional eating in individuals with SMI?
- Do emotional eating and sleep quality affect MetS in relation to mental status in individuals with SMI?
Hypotheses
H1 The group of psychotropic medications routinely used significantly affects MetS levels.
H2 Individuals with SMI have high levels of emotional eating.
H3 As mental status deteriorates, the level of emotional eating increases.
H4 Emotional eating mediates the relationship between mental status and MetS.
H5 Sleep quality mediates the relationship between mental status and MetS.
H6 Emotional eating and sleep quality mediate the relationship between mental status and MetS (multiple mediation model).
H7 As sleep quality decreases, emotional eating increases.
H8 As the level of emotional eating increases, sleep quality deteriorates, which increases the risk of metabolic syndrome.
- Conditions
- Schizophrenia, Bipolar Disorder, Psychiatric Issue, Metabolic Syndrome, Emotional Eating, Sleep
- Keywords
- Schizophrenia, Bipolar Disorder, Metabolic Syndrome, Emotional Eating, Sleep
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Metabolic Syndrome, Emotional Eating, Negotiating
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Syndrome Risk
Participants' current metabolic syndrome risk scores will be measured using the Metabolic Syndrome Risk Index. The total score ranges from 0 to 100. A higher score indicates a higher risk of metabolic syndrome risk.
Measured: Baseline
Secondary outcomes (5)
Emotional eating level
Participants' current emotional eating level scores will be measured using the Salzburg Emotional Eating Scale.
Measured: Baseline
Sleep quality
Participants' current sleep quality scores will be measured using the Cumhuriyet Subjective Sleep Quality Scale.
Measured: Baseline
Positive and negative symptom
Participants' current positive and negative symptom severity. This will be measured using Positive and Negative Syndrome Scale (PANSS). It measures the prevalence of positive and negative syndromes in schizophrenia. Scores range from 7-49 for the Positive and Negative Scales, and from 16-112 for the General Psychopathology Scale. The PANSS total score is a minimum of 30 and a maximum of 210. A higher score indicates higher symptom severity.
Measured: Baseline
Manic symptom
Participants' current manic symptom severity. This will be measured using Young Mania Rating Scale. It measures the prevalence of manic symptom in bipolar disorders. The total score can range from 0 to 60; higher scores indicate more severe manic symptoms.
Measured: Baseline
Depressive symptoms
Participants' current depressive symptoms severity. This will be measured using Hamilton Depression Rating Scale. It measures the prevalence of depressive symptom. In general, the higher the total score, the more severe the depression. HAM-D depression score levels: 10-13 mild; 14-17 mild to moderate; >17 moderate to severe; >23 very severe. Total score ranges from 0 to 68.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start30 May 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melisa BULUT, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411222
- Sponsor's protocol ID
- AIBU-PSK-MB-04
- Status last verified
- Jul 2026
- First submitted
- 5 Feb 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang W, Sun Q, Chen B, Basta M, Xu C, Li Y. Insomnia symptoms are associated with metabolic syndrome in patients with severe psychiatric disorders. Sleep Med. 2021 Jul;83:168-174. doi: 10.1016/j.sleep.2021.03.030. Epub 2021 May 19.
PubMed 34022493Zeron-Rugerio MF, Doblas-Faxeda S, Diez-Hernandez M, Izquierdo-Pulido M. Are Emotional Eating and Other Eating Behaviors the Missing Link in the Relationship between Inadequate Sleep and Obesity? A Systematic Review. Nutrients. 2023 May 12;15(10):2286. doi: 10.3390/nu15102286.
PubMed 37242168Yan H, Huang Z, Lu Y, Qiu Y, Li M, Li J. Associations between metabolic disorders and sleep disturbance in patients with schizophrenia. Compr Psychiatry. 2023 Apr;122:152369. doi: 10.1016/j.comppsych.2023.152369. Epub 2023 Jan 21.
PubMed 36702060Leutner M, Dervic E, Bellach L, Klimek P, Thurner S, Kautzky A. Obesity as pleiotropic risk state for metabolic and mental health throughout life. Transl Psychiatry. 2023 May 30;13(1):175. doi: 10.1038/s41398-023-02447-w.
PubMed 37248222Laaboub N, Dubath C, Ranjbar S, Sibailly G, Grosu C, Piras M, Delessert D, Richard-Lepouriel H, Ansermot N, Crettol S, Vandenberghe F, Grandjean C, Delacretaz A, Gamma F, Plessen KJ, von Gunten A, Conus P, Eap CB. Insomnia disorders are associated with increased cardiometabolic disturbances and death risks from cardiovascular diseases in psychiatric patients treated with weight-gain-inducing psychotropic drugs: results from a Swiss cohort. BMC Psychiatry. 2022 May 17;22(1):342. doi: 10.1186/s12888-022-03983-3.
PubMed 35581641Dakanalis A, Mentzelou M, Papadopoulou SK, Papandreou D, Spanoudaki M, Vasios GK, Pavlidou E, Mantzorou M, Giaginis C. The Association of Emotional Eating with Overweight/Obesity, Depression, Anxiety/Stress, and Dietary Patterns: A Review of the Current Clinical Evidence. Nutrients. 2023 Feb 26;15(5):1173. doi: 10.3390/nu15051173.
PubMed 36904172Godet A, Fortier A, Bannier E, Coquery N, Val-Laillet D. Interactions between emotions and eating behaviors: Main issues, neuroimaging contributions, and innovative preventive or corrective strategies. Rev Endocr Metab Disord. 2022 Aug;23(4):807-831. doi: 10.1007/s11154-021-09700-x. Epub 2022 Jan 4.
PubMed 34984602
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mediating Role of Emotional Eating and Sleep Quality in the Relationship Between Mental State and Metabolic Syndrome in Individuals With Schizophrenia and Bipolar Disorder
- ClinicalTrials.gov ID
- NCT07411222
- Acronym / sponsor ID
- AIBU-PSK-MB-04
- Conditions
- Schizophrenia, Bipolar Disorder, Psychiatric Issue, Metabolic Syndrome, Emotional Eating, Sleep
- Keywords
- Schizophrenia, Bipolar Disorder, Metabolic Syndrome, Emotional Eating, Sleep
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 30 May 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- 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.
In predominantly medication-naïve schizophrenic patients, those exhibiting partial metabolic disorders have significantly worse sleep quality and sleep onset time; poor sleep predicted metabolic dysregulation even after controlling for confounding factors. Mental health, sleep, and eating behavior interact in ways that strongly influence the risk of obesity and MetS. Emotional eating (eating in response to emotions rather than hunger) is central to this network and appears to be closely associated with psychiatric illnesses, particularly depression, anxiety, and sleep disorders. There is a continuing need to elucidate the frequency, level, and relationship of emotional eating with other factors in individuals with SMI. Therefore, this study aims to elucidate this complex relationship, thereby shedding light on new ways to reduce metabolic risks in psychiatric patients.
Detailed description
Research Questions
- Is there a relationship between mental status and MetS in individuals with SMI?
- How does diagnosis (schizophrenia or bipolar disorder) and the group of medications used affect MetS in individuals with SMI?
- What is the level of emotional eating in individuals with SMI?
- Do emotional eating and sleep quality affect MetS in relation to mental status in individuals with SMI?
Hypotheses
H1 The group of psychotropic medications routinely used significantly affects MetS levels.
H2 Individuals with SMI have high levels of emotional eating.
H3 As mental status deteriorates, the level of emotional eating increases.
H4 Emotional eating mediates the relationship between mental status and MetS.
H5 Sleep quality mediates the relationship between mental status and MetS.
H6 Emotional eating and sleep quality mediate the relationship between mental status and MetS (multiple mediation model).
H7 As sleep quality decreases, emotional eating increases.
H8 As the level of emotional eating increases, sleep quality deteriorates, which increases the risk of metabolic syndrome.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals being followed at the Community Mental Health Center, diagnosed with schizophrenia or bipolar disorder, who volunteered to participate in the study and were able to provide written consent.
Key inclusion criteria (7 listed)
- Being registered with the Bolu İzzet Baysal Mental Health and Diseases Hospital Community Mental Health Center,
- Having a severe chronic psychiatric illness (Schizophrenia Spectrum and Other Psychotic Disorders and Bipolar Disorder) followed by the Bolu İzzet Baysal Mental Health and Diseases Hospital Community Mental Health Center for at least 6 months,
- Being in remission (Complete Remission (Pre-Remission): Symptoms remaining below threshold values for at least 2 months (8 weeks). A state of improvement lasting more than 2 months is generally referred to as "remission"),
- Schizophrenia remission definition: 8 diagnostically significant symptoms were selected from the Positive and Negative Syndrome Scale.
- Bipolar disorder remission definition: Complete remission is defined as the absence of acute attacks and the presence of minimal/very mild symptoms.
Key exclusion criteria (3 listed)
- Having a diagnosis of mental retardation,
- Having other neurocognitive disorders, primarily dementia, according to DSM-V (as it can affect the ability to make decisions and give correct answers),
- Not being able to speak or understand Turkish.
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
Metabolic Syndrome Risk
Time frame: Baseline
Participants' current metabolic syndrome risk scores will be measured using the Metabolic Syndrome Risk Index. The total score ranges from 0 to 100. A higher score indicates a higher risk of metabolic syndrome risk.
5 secondary outcomes
Emotional eating level
Time frame: Baseline
Sleep quality
Time frame: Baseline
Positive and negative symptom
Time frame: Baseline
Manic symptom
Time frame: Baseline
Depressive symptoms
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Background: PubMed 34022493Zhang W, Sun Q, Chen B, Basta M, Xu C, Li Y. Insomnia symptoms are associated with metabolic syndrome in patients with severe psychiatric disorders. Sleep Med. 2021 Jul;83:168-174. doi: 10.1016/j.sleep.2021.03.030. Epub 2021 May 19.
- Background: PubMed 37242168Zeron-Rugerio MF, Doblas-Faxeda S, Diez-Hernandez M, Izquierdo-Pulido M. Are Emotional Eating and Other Eating Behaviors the Missing Link in the Relationship between Inadequate Sleep and Obesity? A Systematic Review. Nutrients. 2023 May 12;15(10):2286. doi: 10.3390/nu15102286.
- Background: PubMed 36702060Yan H, Huang Z, Lu Y, Qiu Y, Li M, Li J. Associations between metabolic disorders and sleep disturbance in patients with schizophrenia. Compr Psychiatry. 2023 Apr;122:152369. doi: 10.1016/j.comppsych.2023.152369. Epub 2023 Jan 21.
- Background: PubMed 37248222Leutner M, Dervic E, Bellach L, Klimek P, Thurner S, Kautzky A. Obesity as pleiotropic risk state for metabolic and mental health throughout life. Transl Psychiatry. 2023 May 30;13(1):175. doi: 10.1038/s41398-023-02447-w.
- Background: PubMed 35581641Laaboub N, Dubath C, Ranjbar S, Sibailly G, Grosu C, Piras M, Delessert D, Richard-Lepouriel H, Ansermot N, Crettol S, Vandenberghe F, Grandjean C, Delacretaz A, Gamma F, Plessen KJ, von Gunten A, Conus P, Eap CB. Insomnia disorders are associated with increased cardiometabolic disturbances and death risks from cardiovascular diseases in psychiatric patients treated with weight-gain-inducing psychotropic drugs: results from a Swiss cohort. BMC Psychiatry. 2022 May 17;22(1):342. doi: 10.1186/s12888-022-03983-3.
- Background: PubMed 36904172Dakanalis A, Mentzelou M, Papadopoulou SK, Papandreou D, Spanoudaki M, Vasios GK, Pavlidou E, Mantzorou M, Giaginis C. The Association of Emotional Eating with Overweight/Obesity, Depression, Anxiety/Stress, and Dietary Patterns: A Review of the Current Clinical Evidence. Nutrients. 2023 Feb 26;15(5):1173. doi: 10.3390/nu15051173.
- Background: PubMed 34984602Godet A, Fortier A, Bannier E, Coquery N, Val-Laillet D. Interactions between emotions and eating behaviors: Main issues, neuroimaging contributions, and innovative preventive or corrective strategies. Rev Endocr Metab Disord. 2022 Aug;23(4):807-831. doi: 10.1007/s11154-021-09700-x. Epub 2022 Jan 4.
- Individual participant dataSharing planned: No
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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.
Nur Özgedik Turhan, Psychiatrist contact
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 Bipolar Disorder, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 3 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melisa Bulut, PhD (+905348855882, melisa.bulut@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Syndrome Risk (time frame: Baseline). 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 NCT07411222, which also lists 7 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 27 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.