Influence of rTMS on Symptoms and Cognitive Function in Patients With Psychiatric Disorders

Beijing HuiLongGuan Hospital

Status: Completed

Conditions: Major Depressive Disorder; Schizophrenia

Treatments: Device: rTMS in major depressive disorders patients; Device: rTMS in schizophrenia patients; Device: rTMS in major depressive disorders controls; Device: rTMS in schizophrenia Controls

Study type: Interventional

Funder types: Other

Identifiers

NCT04055181

CASPsy2

Details and patient eligibility

About

The investigators investigated the effects of high frequency (10Hz) repetitive transcranial magnetic stimulation (rTMS) on the symptoms and cognitive functioning in patients with psychiatric disorders

Full description

OBJECTIVE: This study aimed to evaluate the efficacy of high-frequency rTMS over left dorsolateral prefrontal cortex in the treatment of symptoms and cognitive functioning in 200 chronic patients with schizophrenia and 200 patients with major depressive disorders

METHODS:

1. Clinical Trial：The study consists of 4 weeks of treatment.
2. Assess Procedures:

2.1 Primary Outcome Variable-Psychopathology: The psychopathology of patients was assessed by three clinical trained staff, who were blind to treatment protocols, using the Positive and Negative Syndrome Scale (PANSS) or DSM-IV for depression, and repeatable battery for the assessment of neuropsychological status(RBANS).Patients are interviewed at screening, at at baseline, 4 weeks, 16 weeks.

2.2 Side effects: The side effect rating scale (UKU) was used to assess the side effect at baseline, 4 weeks, and 16 weeks.

2.3 Weight gain measurement: weight gain every week

Enrollment: 800 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

For Schizophrenia Patients:

• Diagnosis of schizophrenia by two senior psychiatrists
• Between 18 and 60 years and Han Chinese
• Duration of symptoms at least 12 months
• With unresolved negative symptoms (Negative scale of PANSS ≥20 and positive scale of PANSS < 24)
• Smoking

For Major Depressive Disorder Patients:

• Diagnosis of Major depressive disorder by two senior psychiatrists
• Between 18 and 60 years and Han Chinese
• Duration of symptoms at least 12 months
• Smoking

Exclusion criteria

• Documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, Huntington's disease, multiple sclerosis
• Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
• Severe headache for unknown reasons and cardiovascular diseases, intracranial metals, pacemakers, severe and those receiving electroconvulsive therapy in the past 3 months
• Past history of autoimmune and allergies, hypertension, lung disease, diabetes or cerebrovascular disease), past history of neurological illness (head trauma with loss of consciousness for more than 5 minutes) or family history of epilepsy increasing the risk of seizures
• Education level less than 5 years by subject report
• Receiving or planning to start the psychotherapy during the rTMS treatment or past received psychotherapy 6 months before the current study
• Subjects who suffered from alcohol or illegal drug abuse/dependence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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800 participants in 4 patient groups

rTMS in schizophrenia patients

Active Comparator group

Description:

In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of motor threshold (MT) for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks

Treatment:

Device: rTMS in schizophrenia patients

rTMS in schizophrenia Controls

Sham Comparator group

Description:

In sham rTMS, all procedures were identical to 10Hz Schizophrenia group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.

Treatment:

Device: rTMS in schizophrenia Controls

rTMS in major depressive disorders patients

Active Comparator group

Description:

In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks

Treatment:

Device: rTMS in major depressive disorders patients

rTMS in major depressive disorders controls

Sham Comparator group

Description:

In sham rTMS, all procedures were identical to 10Hz depression group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.

Treatment:

Device: rTMS in major depressive disorders controls