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Status unknownNCT05086133Updated Nov 17, 2022

cTBS on First-episode Drug Naive Patients With Schizophrenia

An interventional study of transcranial magnetic stimulation and sham stimulation in Schizophrenia, sponsored by Central South University. Status unknown at 1 site in China. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-11-17.

Sponsored by Central South University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.

Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.

Read the detailed description

cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.

Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.

02

Conditions studied

  • Schizophrenia

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03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 44 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Central South University is the lead sponsor of 126 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients diagnosed with schizophrenia in accordance with DSM-5
  • The course of the disease less then 2 years
  • Accepting antipsychotics treatment for less then 2 months

Exclusion criteria

Exclusion Criteria:

  • Diagnosed with other mental disease in accordance with DSM-5
  • Comorbid with other severe physiological disease
  • Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before
  • Drug or alcohol abuse
  • Pregnant or lactating Contraindication to rTMS
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    cTBS stimulation

    The participants randomized into experimental group will receive cTBS stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.

    Device: transcranial magnetic stimulation

  • Sham comparator
    Sham stimulation

    The participants randomized into experimental group will receive sham stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.

    Device: sham stimulation

Interventions

  • Devicetranscranial magnetic stimulation

    transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total.

  • Devicesham stimulation

    TMS coil vertical to the brain surface, with same protocol as cTBS

06

What researchers measure

Primary outcomes

  1. Three-Factor Eating Questionnaire

    min value 21, max value 84. The higher scores mean more unhealthy eating behavior.

    Time frame: Change from Baseline to 6days and 36days

  2. MCCB

    The MATRICS™ Consensus Cognitive Battery

    Time frame: Change from Baseline to 6days and 36days

  3. The positive and negative syndrome scale

    min score 30, max score 210. The higher score means more severe symptoms.

    Time frame: Change from Baseline to 6days and 36days

  4. BMI

    body mass index

    Time frame: Change from Baseline to 6days and 36days

Secondary outcomes

  1. Resting EEG

    resting EEG (electroencephalogram) with eyes opened, eye closed and natural stimulation. The reEEG power spectra, functional connection will be calculated.

    Time frame: Change from Baseline to 6days and 36days

  2. fasting glucose

    in mmol/l

    Time frame: Change from Baseline to 6days and 36days

  3. Triglyceride

    in mmol/l

    Time frame: Change from Baseline to 6days and 36days

  4. Total Cholesterol

    in mmol/l

    Time frame: Change from Baseline to 6days and 36days

  5. Low Density Lipoprotein

    in mmol/l

    Time frame: Change from Baseline to 6days and 36days

  6. High Density Lipoprotein

    in mmol/l

    Time frame: Change from Baseline to 6days and 36days

07

Study locations

1 site
  • Central South University
    Changsha, Hunan 410000, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05086133
Lead sponsor
Central South University
Collaborators
Shanghai Mental Health Center
Responsible party
Renrong Wu (Professor, Central South University) — Principal investigator
First posted
Oct 20, 2021
Start date
Nov 20, 2021
Primary completion
Nov 15, 2022
Completion
Jun 1, 2023 (estimated)
Last update
Nov 17, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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