Repetitive Transcranial Magnetic Stimulation for the Treatment of Negative Symptoms in Schizophrenia Patients.

Schizophrenia Clinical Trial

Official title:

A Randomized Double-blind Controlled Study of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02842034
• Other study ID #: rTMS-negative symptoms
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2016
• Last updated: February 22, 2018
• Start date: July 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: Shanghai Mental Health Center
• Contact: Dengtang Liu, MD
• Phone: +86 21 64387250-73775
• Email: erliu110[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to determine whether high frequency repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia patients

Description:

The principal objective of this trial is to investigate the effect of high frequency rTMS on negative symptoms in schizophrenia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 55 Years

Eligibility

Inclusion Criteria:

• The diagnosis of schizophrenia according to DSM-IV;

• 18~55 years old;

• schizophrenic illness duration longer than one year;

• The sum of negative scores in the range Positive and negative symptom score (PANSS) must be 20 points or higher, at least one item from the area of negative symptoms (N1-N7) must be = 4 points (at least moderate, clinically significant symptoms), and improvement in negative symptom-sum (measuring by PANSS) must be 10% or lower during the last two weeks before rTMS stimulation.

• Have a stable and consistent drug treatment at least two weeks prior the rTMS treatment;

• Able to adhere to the treatment schedule;

• IQ=80;

• Dextromanual, normal vision and hearing;

• Signed an informed consent

Exclusion Criteria:

• rTMS contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure;

• Acute risk of suicide and impulse;

• patients to be diagnosed according to DSM-IV for substance abused, development delayed;

• suffering from serious physical disease and can not accept the treatment;

• history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG;

• difficult to maintain the current drug treatment for at least 1 month;

• undergoing ECT or MECT in last 3 months;

• current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
Stimulate the dorsomedial prefrontal cortex for 4 weeks.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in Letter-Number Span		3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Other	Change from baseline in Wechsler Working Memory		3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Other	Change from baseline in Resting-state functional MRI:TR=2000 ms,TE=35 ms,FA=90,Matrix =64×64,Nex=1,FOV=256 mm,thickness=4 mm,Gap=0,scanning 33 slices?		2 times (Before treatment,immediately after treatment)
Other	Change from baseline in diffusion tensor imaging (DTI):TR=8500,TE=87, matrix size=64×64, FOV=230, slices thickness = 3 mm, diff directions=30,scanning 46 slices		2 times (Before treatment,immediately after treatment)
Other	Change from baseline in Magnetic Resonance Spectroscopy (MRS) of DMPFC		2 times (Before treatment,immediately after treatment)
Primary	Change from baseline in clinical improvement of negative symptoms (Scale for Assessment of Negative Symptoms [SANS], and Positive and Negative Syndrome Scale [PANSS] negative symptoms subscale)		3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Secondary	Change from baseline in Positive and Negative Syndrome Scale [PANSS] positive symptoms subscale		3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Secondary	Change from baseline in Calgary Depression Scale for Schizophrenia [CDSS]		3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Secondary	Change from baseline in clinical global impression [CGI]		3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Secondary	Change from baseline in WHO Disability Assessment Schedule 2.0 [WHODAS 2.0]		3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Secondary	Change from baseline in Simpson-Angus Scale [SAS]		3 times (Before treatment,immediately after treatment,4 weeks after treatment)
Secondary	Change from baseline in Clinician Rated Dimensions of Psychosis Symptom [CRDPS]		3 times (Before treatment,immediately after treatment,4 weeks after treatment)