Clinical trial NCT04055181: Influence of rTMS on Symptoms and Cognitive Function in Patients With Psychiatric Disorders
Official title: Influence of rTMS on Symptoms and Cognition in Patients With Psychiatric Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Major Depressive Disorder
Keywords: schizophrenia
smoking
rTMS
major depressive disorder
Lead sponsor: Beijing HuiLongGuan Hospital
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: symptoms assessed on PANSS
timeFrame: 4 weeks
measure: cognitive functioning assessed on RBANS
timeFrame: 4 weeks
measure: major depressive disorders assessed on Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
timeFrame: 4 weeks
Secondary outcomes:
measure: Side effect assessed on UKU
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chaohu
country: China
facility: Chaohu Hospital of Anhui medical unviersity
state: Anhui
city: Zhongshan
country: China
facility: Zhongshan Third People's Hospital
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Mental Health Center
state: Hubei
city: Ganzhou
country: China
facility: Ganzhou Third Hospital
state: Jiangxi
city: Ning'an
country: China
facility: Ningxia Mental Health Center
state: Ningxia
city: Xi'an
country: China
facility: Xi'an Mental Health Center
state: Shanxi
Study officials:
affiliation: Institute of Psychology, Chinese Academy of Sciences
name: Xiang Y Zhang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kozak K, Sharif-Razi M, Morozova M, Gaudette EV, Barr MS, Daskalakis ZJ, Blumberger DM, George TP. Effects of short-term, high-frequency repetitive transcranial magnetic stimulation to bilateral dorsolateral prefrontal cortex on smoking behavior and cognition in patients with schizophrenia and non-psychiatric controls. Schizophr Res. 2018 Jul;197:441-443. doi: 10.1016/j.schres.2018.02.015. Epub 2018 Feb 24.
citation: Prikryl R, Ustohal L, Kucerova HP, Kasparek T, Jarkovsky J, Hublova V, Vrzalova M, Ceskova E. Repetitive transcranial magnetic stimulation reduces cigarette consumption in schizophrenia patients. Prog Neuropsychopharmacol Biol Psychiatry. 2014 Mar 3;49:30-5. doi: 10.1016/j.pnpbp.2013.10.019. Epub 2013 Nov 6.
citation: Huang W, Shen F, Zhang J, Xing B. Effect of Repetitive Transcranial Magnetic Stimulation on Cigarette Smoking in Patients with Schizophrenia. Shanghai Arch Psychiatry. 2016 Dec 25;28(6):309-317. doi: 10.11919/j.issn.1002-0829.216044.
citation: Zvolensky MJ, Bakhshaie J, Sheffer C, Perez A, Goodwin RD. Major depressive disorder and smoking relapse among adults in the United States: a 10-year, prospective investigation. Psychiatry Res. 2015 Mar 30;226(1):73-7. doi: 10.1016/j.psychres.2014.11.064. Epub 2014 Dec 9.
citation: Benadhira R, Thomas F, Bouaziz N, Braha S, Andrianisaina PS, Isaac C, Moulier V, Januel D. A randomized, sham-controlled study of maintenance rTMS for treatment-resistant depression (TRD). Psychiatry Res. 2017 Dec;258:226-233. doi: 10.1016/j.psychres.2017.08.029. Epub 2017 Aug 18.