How genetics, behaviour, and environment can contribute to a condition called metabolic syndrome in people who are taking antipsychotic medication

Metabolic syndrome in people treated with antipsychotics: a multimethod investigation of genetic, behavioural and environmental risk factors

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN18419418

Enrollment

Registered

2023-07-11

Start date

2024-05-01

Completion date

Unknown

Last updated

2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic, behavioural and environmental risk factors of metabolic syndrome in people treated with antipsychotics (schizophrenia, bipolar disorder, neurodevelopmental disorder) Mental and Behavioural Disorders

Interventions

1. To identify risk factors for metabolic syndrome (MetS) using a case-control design. We will recruit (among both adult and paediatric population) two groups of subjects: "Cases" (MetS+) and sex- and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age groups: 6-17 years; 18-45 years; and 46-65 years In each stratum, using medical records we will select 25 "cases" treated with APs for at least 1 year. For each case, we will recruit a matched "control".

Exclusion criteria

Exclusion criteria: 1. Intention to move in the subsequent year 2. Severe cognitive impairment 3. Severe substance use disorder

Design outcomes

Primary

Measure	Time frame
Part 1 (case-control study) Familiarity for MetS and both psychological and functional risk factors: 1.1. BPRS to assess the presence and severity of psychopathology 1.2. CGI to measure illness severity (CGIS). 1.3. WHODAS 2.0 to measure the impact of health conditions on functioning in six life domains (Cognition, Mobility, Self-care, Getting along, Life activities, Participation). 1.4. SLOF: (1) physical functioning, (2) personal care skills, (3) interpersonal relationships, (4) social acceptability, (5) activities of community living and (6) work skills. 1.5. ECI: method for categorizing medical comorbidities based on ICD categories. 1.6. LEDS: in-depth, semi-structured interview investigating the number, nature and severity of acute (events) and ongoing stressors (difficulties) around ten key life domains experienced in a set study period. 1.7. EQ5D: Health questionnaire to evaluate quality of life 1.8. PSQI: to evaluate the quality and patterns of sleep 1.9. SF-36: self-reported measure of quality of life 1.10. DBC-P: to assess behavioural and emotional problems of young people aged 4-18 years with developmental and intellectual disabilities (UO2). 1.11. Tanner Staging Scale: used to rate sexual maturity in children, adolescents and adults based on external primary and secondary sex characteristics (UO2). 1.12. PedsQL: brief, 23-item measure of health-related quality of life in children and young people, to be filled by parents (Proxy Report) as well as children and young people (Self-Report) (UO2). 1.13. DAWBA: package of interviews, questionnaires and rating techniques designed to generate ICD-10 and DSM-IV or DSM-5 psychiatric diagnoses on 2-17 year olds; we will use only the background section for the assessment of family and environmental risk factors (UO2). 1.14. WHOQOL-BREF: self-administered questionnaire comprising 26 items on the individual's perceptions of their health and well-being over the previous two weeks. 1.15. CBCL: is a widely used caregiv	—

Measure

Time frame

Part 1 (case-control study) Familiarity for MetS and both psychological and functional risk factors: 1.1. BPRS to assess the presence and severity of psychopathology 1.2. CGI to measure illness severity (CGIS). 1.3. WHODAS 2.0 to measure the impact of health conditions on functioning in six life domains (Cognition, Mobility, Self-care, Getting along, Life activities, Participation). 1.4. SLOF: (1) physical functioning, (2) personal care skills, (3) interpersonal relationships, (4) social acceptability, (5) activities of community living and (6) work skills. 1.5. ECI: method for categorizing medical comorbidities based on ICD categories. 1.6. LEDS: in-depth, semi-structured interview investigating the number, nature and severity of acute (events) and ongoing stressors (difficulties) around ten key life domains experienced in a set study period. 1.7. EQ5D: Health questionnaire to evaluate quality of life 1.8. PSQI: to evaluate the quality and patterns of sleep 1.9. SF-36: self-reported measure of quality of life 1.10. DBC-P: to assess behavioural and emotional problems of young people aged 4-18 years with developmental and intellectual disabilities (UO2). 1.11. Tanner Staging Scale: used to rate sexual maturity in children, adolescents and adults based on external primary and secondary sex characteristics (UO2). 1.12. PedsQL: brief, 23-item measure of health-related quality of life in children and young people, to be filled by parents (Proxy Report) as well as children and young people (Self-Report) (UO2). 1.13. DAWBA: package of interviews, questionnaires and rating techniques designed to generate ICD-10 and DSM-IV or DSM-5 psychiatric diagnoses on 2-17 year olds; we will use only the background section for the assessment of family and environmental risk factors (UO2). 1.14. WHOQOL-BREF: self-administered questionnaire comprising 26 items on the individual's perceptions of their health and well-being over the previous two weeks. 1.15. CBCL: is a widely used caregiv

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026