iTBS for Increased Appetite Induced by Antipsychotics
ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCentral South University
About this trial
Antipsychotics are prone to cause metabolic side effects, including weight gain, hyperglycemia, insulin resistance, hyperlipidemia and so on, leading to a 2-3 times higher risk of death in patients with schizophrenia compared to healthy people. Conventional high-frequency rTMS have been used to treat people with obesity and showed certain effectiveness. However, studies involving schizophrenia patients and intermittent theta burst (iTBS) mode are rarely seen. The goal of this clinical trial is to evaluate the efficacy and safety of iTBS on ameliorating increased appetite induced by antipsychotics in people with schizophrenia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18-40 years old;
Meeting the diagnostic criteria for schizophrenia in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition);
BMI ≥ 25kg/m 2 or over 10% weight gain after taking antipsychotics in the last year;
Not receiving TMS therapy in the past month;
Disqualifiers
Other severe mental illnesses, mental retardation, dementia and severe cognitive impairment according to diagnostic criteria of ICD-10 or DSM-5;
Abnormal brain structure or function owing to any major physical disease, neurological disease, traumatic brain injury, etc.;
Metallic implants, pacemakers, epilepsy history or other contraindications of TMS;
Suicidal thoughts or behaviors;
Trial design
Design model
Parallel
Treatments tested in this trial
Active iTBS
DeviceMag-TD
Sham iTBS
DeviceMag-TD
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: active stimulationActive comparator 1 intervention
Group B: Sham stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in body mass index (BMI)
Weight gain will be assessed by BMI, caculated by weight in kilograms divided by height in meters squared
Time frame
Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatmentSecondary outcomes
1
Changes in Positive and Negative Symptom Scale (PANSS)
Range from 30 to 210, higher score indicates more severe positive and negative symptoms.
Time frame
Baseline and 4 weeks post-treatment2
Changes in Calgary Depression Scale for Schizophrenia (CDSS)
Range from 0 to 27, higher score indicates more severe affective symptoms.
Time frame
Baseline and 4 weeks post-treatment3
Changes in the Clinical Global Impressions (CGI)
The Clinical Global Impressions (CGI) scale, quantifying the severity of psychopathology, ranging from 1 to 7 and improvements, ranging from 1 to 7 after treatments
Time frame
Baseline and 4 weeks post-treatment4
Changes in brain perfusion.
The arterial spin labeling (ASL) pulse sequences to quantify the cerebral blood flow (CBF).
Time frame
Baseline, after 5 treatment days and 4 weeks post-treatmentSponsors and contacts
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Source ClinicalTrials.gov