Schizophrenia spectrum disorder
Conditions
Interventions
SGLT2 inhibitor group :Empagliflozin 10mg daily with lifestyle intervention
Placebo group :Placebo with lifestyle intervention
Sponsors
Tai Po Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1) Who are 18-64 years old; 2) Who met criteria for schizophrenia spectrum and other psychotic disorders on Chinese-bilingual Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Axis I, patient version (SCID-I) except for substance/medication-induced psychotic disorder, psychotic disorder due to another medical condition, catatonia associated with another mental disorder, catatonic disorder due to another medical condition, and unspecified catatonia; 3) Who are receiving at least one of the targeted atypical antipsychotics -- clozapine, olanzapine, quetiapine, risperidone or paliperidone, for 6 months with its dosage and concomitant psychiatric medications not changed over the past 1 month prior to study entry; 4) Who are Asians with Body Mass Index (BMI) = 23 kg/m2 (Classified as overweight or obese according to World Health Organization (WHO)’s classification for Asia-Pacific); 5) Who are able to understand spoken instructions in Cantonese and are able to read traditional Chinese; 6) Being clinically stable as assessed by their treating psychiatrist and having a Clinical Global Impressions scale severity rating (CGI-S) =4 (moderately ill) 7) Who are able to give informed consent.
Exclusion criteria
Exclusion criteria: 1) Who had received a psychiatric diagnosis other than schizophrenia spectrum disorder as confirmed by SCID-I, had learning disability or had any active substance abuse or dependence for the past six months (except for nicotine); 2) With evidence of active liver, thyroid or renal dysfunction, cardiovascular disease, uncontrolled hypertension, diabetes mellitus or malignancy, defined as: i. Liver dysfunction: liver transaminases >3 times upper normal limit; ii. Renal dysfunction: estimated glomerular filtration rate (eGFR) 180mmHg or diastolic blood pressure >100 mmHg; v. Diabetes mellitus: HbA1c >6.4% (conventional unit). 3) Who had used any medication for weight loss within the preceding month prior to study entry; 4) Who are having treatment with oral corticosteroids; 5) Suffering from recurrent genitourinary infection, defined as =2 infections in past six months or =3 infections in the past year; 6) Who are in pregnancy or lactation within recent 3 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight (kg) ;Body Mass Index (BMI)(kg/m2); | — |
Secondary
| Measure | Time frame |
|---|---|
| Waist circumference (cm);Low-density lipoprotein (LDL) (mmol/L);High-density lipoprotein (HDL) (mmol/L);Total triglycerides (TG) (mmol/L) ;Blood pressure (mmHg);HbA1c (mmol/mol);Fasting glucose (mmol/L); | — |
Countries
China
Contacts
Public ContactWong Sin YIng
Tai Po Hospital
Outcome results
None listed