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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02451371
Other study ID # 1501-022-638
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received April 27, 2015
Last updated December 28, 2016
Start date August 2016
Est. completion date December 2016

Study information

Verified date August 2016
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

The purpose of this study is to exploratively evaluate the efficacy and safety of transcranial direct current stimulation (tDCS) in patients with schizophrenia who experience persistent auditory verbal hallucinations after adequate antipsychotics therapy for over three months.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria:

- Patients with schizophrenia by the Diagnostic and Statistical Manual of Mental Disorders, Fourth edition, Text Revision (DSM-IV-TR)

- Presence of auditory hallucination after three months' trial of antipsychotics of adequate dose

- The Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) score is at least 8

Exclusion Criteria:

- Significant brain pathology including head trauma, seizure, meningitis

- Intellectual disability (IQ < 70)

- Severe personality disorder

- Substance use disorder (except nicotine)

- Severe medical illness

- Disability in the sensory organs

- Pregnancy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
tDCS
2mA direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Auditory hallucination change by changes in The Psychotic Symptom Rating Scales (PSYRATs) Auditory hallucinations subscale score Auditory hallucination change by changes in the auditory hallucinations subscale from the Psychotic Symptom Rating Scales approximately 2 weeks No
Secondary Electroencephalography - resting change in lagged phase synchronization value
change in microstate connectivity value
approximately 2 weeks No
Secondary Electroencephalography - P300 peak change in P300 peak amplitude during auditory oddball task
change in P300 peak latency during auditory oddball task
approximately 2 weeks No
Secondary Electroencephalography - P300 source change in P300 source strength during auditory oddball task
change in P300 source location during auditory oddball task
approximately 2 weeks No
Secondary Electroencephalography - P50 change in T/C ratio (testing stimulus/conditioning stimulus) during paired click test
change in T/C difference (conditioning stimulus-testing stimulus) during paired click test
change in T/C difference (testing stimulus - conditioning stimulus) during paired click test
approximately 2 weeks No
Secondary Electroencephalography - ERN (error-related negativity) peak change in ERN peak amplitude during flanker task
change in ERN peak latency during flanker task
approximately 2 weeks No
Secondary Electroencephalography - ERN (error-related negativity) source change in ERN source strength during flanker task
change in ERN source location during flanker task
approximately 2 weeks No
Secondary Electroencephalography - ERN (error-related negativity) frequency activity change in ERN beta band activity during flanker task
change in ERN theta band activity during flanker task
change in ERN delta band activity during flanker task
approximately 2 weeks No
Secondary Brain Magnetic Resonance Image (MRI) - T1 Image grey matter thickness change in grey matter thickness approximately 2 weeks No
Secondary Brain Magnetic Resonance Image (MRI) - T1 Image grey matter volume change in grey matter volume approximately 2 weeks No
Secondary Brain MRI - functional MRI change in Pearson's correlation coefficient of BOLD signals approximately 2 weeks No
Secondary Brain MRI - Diffusion Tensor Image (DTI) functional anisotropy change in fractional anisotropy approximately 2 weeks No
Secondary Brain MRI - Diffusion Tensor Image (DTI) mean diffusivity change in mean diffusivity approximately 2 weeks No
Secondary Brain MRI - Diffusion Tensor Image (DTI) radial diffusivity change in radial diffusivity approximately 2 weeks No
Secondary Brain MRI - Diffusion Tensor Image (DTI) axial diffusivity change in axial diffusivity approximately 2 weeks No
Secondary Brain MRI - myelin image change in myelin imaging intensity value approximately 2 weeks No
Secondary Kicer values change with treatment in striatum assessed by 18F-DOPA Positron Emission Tomography (PET) - Kicer values change with treatment in striatum approximately 2 weeks No
Secondary Magnetic Resonance Spectroscopy (MRS) - N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment approximately 2 weeks No
Secondary Auditory hallucination change by changes in the Auditory Hallucination Rating Scale (AHRS) score Auditory hallucination change by changes in the Auditory Hallucination Rating Scale score approximately 2 weeks No
Secondary Auditory hallucination change by changes in the Korean Version of Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) score Auditory hallucination change by changes in the Korean Version of Hamilton Program for Schizophrenia Voices Questionnaire score approximately 2 weeks No
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