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SchizophreniaPhase 1/2NCT02451371

Treatment of Refractory Auditory Verbal Hallucinations With tDCS in Schizophrenia

A Phase 1/2 study testing tDCS in people with Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 19 to 50 years
Conditions the study is for
Schizophrenia
What is being tested?
tDCS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSouth Korea
Study dates
Aug 2016to Dec 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: A Pilot Study for the Treatment of Refractory Auditory Verbal Hallucinations With Transcranial Direct Current Stimulation(tDCS) in Patients With Schizophrenia

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.

Conditions
Schizophrenia
Being tested
tDCS
Keywords
Schizophrenia, Refractory auditory hallucination, tDCS
Medical subject headings
Schizophrenia, Hallucinations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCSDevice

    Also called YDT-201N

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

Study groups in NCT02451371
Study groupRoleWhat they receive
tDCSExperimentalPatients with schizophrenia to receive tDCS treatment
Receives: Device: tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: approximately 2 weeks

Secondary outcomes (19)

  1. Electroencephalography - resting

    • change in lagged phase synchronization value
    • change in microstate connectivity value

    Measured: approximately 2 weeks

  2. Electroencephalography - P300 peak

    • change in P300 peak amplitude during auditory oddball task
    • change in P300 peak latency during auditory oddball task

    Measured: approximately 2 weeks

  3. Electroencephalography - P300 source

    • change in P300 source strength during auditory oddball task
    • change in P300 source location during auditory oddball task

    Measured: approximately 2 weeks

  4. 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

    Measured: approximately 2 weeks

  5. Electroencephalography - ERN (error-related negativity) peak

    • change in ERN peak amplitude during flanker task
    • change in ERN peak latency during flanker task

    Measured: approximately 2 weeks

  6. Electroencephalography - ERN (error-related negativity) source

    • change in ERN source strength during flanker task
    • change in ERN source location during flanker task

    Measured: approximately 2 weeks

  7. 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

    Measured: approximately 2 weeks

  8. Brain Magnetic Resonance Image (MRI) - T1 Image grey matter thickness

    change in grey matter thickness

    Measured: approximately 2 weeks

  9. Brain Magnetic Resonance Image (MRI) - T1 Image grey matter volume

    change in grey matter volume

    Measured: approximately 2 weeks

  10. Brain MRI - functional MRI

    change in Pearson's correlation coefficient of BOLD signals

    Measured: approximately 2 weeks

  11. Brain MRI - Diffusion Tensor Image (DTI) functional anisotropy

    change in fractional anisotropy

    Measured: approximately 2 weeks

  12. Brain MRI - Diffusion Tensor Image (DTI) mean diffusivity

    change in mean diffusivity

    Measured: approximately 2 weeks

  13. Brain MRI - Diffusion Tensor Image (DTI) radial diffusivity

    change in radial diffusivity

    Measured: approximately 2 weeks

  14. Brain MRI - Diffusion Tensor Image (DTI) axial diffusivity

    change in axial diffusivity

    Measured: approximately 2 weeks

  15. Brain MRI - myelin image

    change in myelin imaging intensity value

    Measured: approximately 2 weeks

  16. Kicer values change with treatment in striatum assessed by 18F-DOPA Positron Emission Tomography (PET)

    • Kicer values change with treatment in striatum

    Measured: approximately 2 weeks

  17. Magnetic Resonance Spectroscopy (MRS)

    • N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment

    Measured: approximately 2 weeks

  18. 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

    Measured: approximately 2 weeks

  19. 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

    Measured: approximately 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2015 (estimated)
  2. Study startAug 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02451371
Sponsor's protocol ID
1501-022-638
Status last verified
Aug 2016
First submitted
27 Apr 2015
Last updated
30 Dec 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing tDCS in people with Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Auditory hallucination change by changes in The Psychotic Symptom Rating Scales (PSYRATs) Auditory hallucinations subscale score (time frame: approximately 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02451371.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2016.

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