Bipolar disorder
Conditions
Interventions
The control group:Healthy lifestyle education and therapy
Experimental group1:Orlistat capsule 0.12bid and healthy lifestyle education were added.
Experimental group2:Stop the original medication, change to lurasidone and healthy lifestyle education treatment
Experimental group3:RTMS treatment was added twice a week and healthy lifestyle education.
Sponsors
The First Affiliated Hospital of Zhejiang University Medical College
Eligibility
Sex/Gender
All
Age
13 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent, willing to participate in the trial and receive treatment; 2. Aged 13 to 60 years, male or female; 3. Outpatient and inpatient patients who meet the DSM-5 diagnostic criteria for bipolar disorder; 4. Received a stable dose of second-generation antipsychotics (SGA) for at least 30 days, and the condition was stable for at least 30 days as assessed by CGI-I; 5. BMI>=24kg/m2 or the above-mentioned complications: 1. Excessive appetite, unbearable hunger before meals, and more food intake per meal; 2. Combined with hyperglycemia, hypertension, dyslipidemia and fatty liver; 3. Combined with weight bearing Joint pain; 4. Dyspnea caused by obesity or obstructive sleep apnea syndrome; 6.BMI>=28kg/m2; 7. Weight gain (>10% of baseline body weight) while taking SGA; 8. Have a good audio-visual level to complete the examinations necessary for the study.
Exclusion criteria
Exclusion criteria: 1. Exclude organic mental disorders, mental disorders caused by psychoactive substances, schizophrenia and mental retardation; current or previous diagnosis of anorexia nervosa or bulimia; 2. Exclude serious physical diseases such as heart, liver, kidney, endocrine, blood system or any major diseases that may affect body weight or physical activity; 3. Previous history of head injury or epilepsy; participants with abnormal brain MRI findings were excluded from the study; 4. Body metal implants, pacemakers and any contraindications to MRI or rTMS; 5. Known allergy to lurasidone or orlistat; 6. Exclude pregnant or lactating women, or those who plan to become pregnant; 7. Exclude the use of two or more second-generation antipsychotic drugs and changes in psychotropic drugs or doses within the past 30 days; 8. Exclude taking any drugs that affect glucose, insulin or lipid levels; 9. Recent use of weight loss medication or a very low-calorie diet.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight;Waist circumference;Hip circumference;Blood pressure;Near-infrared functional brain imaging;Function Magnetic Resonance Imaging; | — |
Countries
China
Contacts
Public ContactHuang Manli
The First Affiliated Hospital of Zhejiang University Medical College
Outcome results
None listed