NCT07411222

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Apr 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

February 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 5, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

SchizophreniaBipolar DisorderMetabolic SyndromeEmotional EatingSleep

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (5)

  • Emotional eating level

    Baseline

  • Sleep quality

    Baseline

  • Positive and negative symptom

    Baseline

  • Manic symptom

    Baseline

  • Depressive symptoms

    Baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 34022493BACKGROUND
  • Zeron-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.

    PMID: 37242168BACKGROUND
  • Yan 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.

    PMID: 36702060BACKGROUND
  • Leutner 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.

    PMID: 37248222BACKGROUND
  • Laaboub 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.

    PMID: 35581641BACKGROUND
  • Dakanalis 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.

    PMID: 36904172BACKGROUND
  • Godet 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.

    PMID: 34984602BACKGROUND

MeSH Terms

Conditions

SchizophreniaBipolar DisorderMetabolic SyndromeEmotional EatingNegotiating

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesFeeding BehaviorBehaviorCommunication

Central Study Contacts

Melisa Bulut, PhD

CONTACT

Nur Özgedik Turhan, Psychiatrist

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant PhD

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share