An interventional study of Active 4.5Hz θ tACS Stimulation and Active 6Hz θ tACS Stimulation in Schizophrenia Disorder, sponsored by Anhui Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Anhui Medical University · Not applicable, Interventional, and Treatment
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Among 248 studies in Schizophrenia with a site in China — 62 open to participants now, 66 under way, 4 of them phase 3. Schizophrenia · China.
Among the 248 studies in Schizophrenia with a site in China, this one is the 80th largest by planned enrollment of the 213 interventional ones that give a count, is one of 24 that started in 2026, is one of 107 with no phase, reaches primary completion later than 58 of the 65 other live ones, and was the 246th registered.
3,567 studies on the registry are indexed under Schizophrenia; 492 are open to participants now.
Browse Schizophrenia studies →62 of the 248 studies in Schizophrenia with a site in China are open now. Recruiting first, the newest first:
Second Xiangya Hospital of Central South University · Sites in China
Ages 18–60
Central South University · Sites in China
Ages 18–50
Second Xiangya Hospital of Central South University · Sites in China
Ages 18–60
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University · Sites in China
Ages 18–65
Central South University · Sites in China
Ages 18–50
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 332 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 258 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
248 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 16 · Phase 3 38 · Phase 4 33
First in 2002; this study’s year is marked. 24 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is above the median of 71 across 2,945 interventional studies indexed under Schizophrenia.
Median enrollment 100 across the 213 interventional studies, 300 across the 35 observational. Of the 118 that completed or were terminated, 21 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
67 of 248 have an industry lead sponsor. The 10 most frequent:
Anhui Medical University is the lead sponsor of 105 studies on the registry; 51 are open to participants now.
Anhui Medical University has 5 studies filed under Schizophrenia — fewer than ten, so there is no comparison to draw.
19 of the studies in Schizophrenia with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06112067Shanghai Mental Health CenterEfficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders | 2026-11 |
| NCT07521683NeuShen TherapeuticsA Phase II Clinical Study to Evaluate the Efficacy and Safety of NS-136 in the Treatment of Schizophrenia | 2026-11 |
| NCT06802939Shanghai Mental Health CenterRTMS for Refractory Auditory Hallucinations Based on Personalized Targets Using Magnetoencephalography | 2026-12-10 |
| NCT07493551CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.A Bioequivalence Study of PP3M in Patients With Schizophrenia | 2026-12-31 |
| NCT07356765Tianjin Anding HospitalBerberine in Treating Negative Symptoms of Schizophrenia: Clinical Efficacy and Mechanisms | 2027-01 |
Add all 19 to your calendar (.ics) → With an account.
Among the 248 studies in Schizophrenia with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a double-blind, sham-controlled randomized study to test whether theta transcranial alternating current stimulation (theta tACS) at 4.5 Hz or 6 Hz, added to standard clinical care, improves symptoms of schizophrenia and is safe and well tolerated. Approximately 150 adults aged 18 to 60 years with schizophrenia will be randomly assigned equally to one of three groups: active 4.5 Hz tACS, active 6 Hz tACS, or sham tACS. Both participants and outcome assessors will be masked to group assignment.
All participants will continue their usual clinical treatment. They will receive one 40-minute tACS session per day over 10 working days (10 sessions total). Symptom assessments will take place at baseline, immediately after the stimulation period, Day 30, and Day 56. Magnetic resonance imaging (MRI) scans will be collected at baseline and post-stimulation. Adverse events will be monitored throughout the study.
The primary goal is to compare whether active theta tACS leads to a greater reduction in overall schizophrenia symptoms from baseline to Day 15 relative to sham tACS. Secondary assessments include symptom changes at other follow-up time points, changes in specific symptom domains, treatment completion rate, safety, and brain imaging changes.
This randomized, double-blind, parallel-group, sham-controlled trial aims to evaluate the efficacy, safety and tolerability of two theta-band tACS protocols (4.5 Hz and 6 Hz) as an add-on intervention for adults with schizophrenia. One hundred and fifty eligible participants will be allocated in a 1:1:1 ratio to 4.5 Hz active tACS, 6 Hz active tACS, or sham tACS. All participants maintain stable standard clinical care during the trial. The stimulation schedule consists of 40-minute daily sessions on 10 consecutive working days. Clinical symptom ratings are scheduled at baseline, post-intervention, Day 30 and Day 56. Structural and functional MRI data are acquired at baseline and post-intervention to explore brain correlates of treatment response. Adverse events are actively monitored at all study visits. The primary outcome is the change in total schizophrenia symptom severity from baseline to Day 15, comparing active stimulation arms versus sham. Secondary outcomes include longitudinal symptom trajectories, domain-specific symptom changes, intervention adherence, safety outcomes, and MRI-derived brain measures.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
participants will receive active 4.5Hz tACS once daily for 10 work days. The central target electrode was placed over F3, with four surrounding return electrodes positioned at FP1, Fz, C3, and F7. Sinusoidal theta-band alternating current was delivered between the central target electrode and the four return electrodes; polarity reverses continuously during stimulation, so no fixed anode or cathode is present.Sinusoidal 4.5Hz theta-band tACS was delivered at a peak current of 2 mA. Each of the ten stimulation sessions lasted 40 minutes, with a 30-second ramp-up and a 30-second ramp-down period.
Device: Active 4.5Hz θ tACS Stimulation
participants will receive active 6Hz tACS once daily for 10 work days. The central target electrode was placed over F3, with four surrounding return electrodes positioned at FP1, Fz, C3, and F7. Sinusoidal theta-band alternating current was delivered between the central target electrode and the four return electrodes; polarity reverses continuously during stimulation, so no fixed anode or cathode is present.Sinusoidal 6Hz theta-band tACS was delivered at a peak current of 2 mA. Each of the ten stimulation sessions lasted 40 minutes, with a 30-second ramp-up and a 30-second ramp-down period.
Device: Active 6Hz θ tACS Stimulation
The sham tACS arm uses the identical electrode montage: one central target electrode at F3 and four surrounding return electrodes at FP1, Fz, C3, and F7. Each session follows the same 40-minute timeline and identical 30-second ramp-up and 30-second ramp-down procedures as the active stimulation arms. Sinusoidal theta-band current is delivered only during the ramp-up and ramp-down phases. No sustained alternating current is applied for the remainder of the session. All other procedural aspects, including device setup, skin preparation, and participant instructions, are identical to the active arms to preserve masking. Participants continue stable standard clinical care throughout the study.
Device: sham tACS Stimulation
The montage uses one central target electrode at F3 and four surrounding return electrodes at FP1, Fz, C3, and F7. Sinusoidal theta-band tACS at 4.5 Hz is delivered at a peak current of 2 mA. Each of the ten stimulation sessions lasts 40 minutes, with a 30-second ramp-up and a 30-second ramp-down period. Current polarity reverses continuously during stimulation, so no fixed anode or cathode is defined. Participants continue stable standard clinical care throughout the trial.
The montage uses one central target electrode at F3 and four surrounding return electrodes at FP1, Fz, C3, and F7. Sinusoidal theta-band tACS at 6 Hz is delivered at a peak current of 2 mA. Each of the ten stimulation sessions lasts 40 minutes, with a 30-second ramp-up and a 30-second ramp-down period. Current polarity reverses continuously during stimulation, so no fixed anode or cathode is defined. Participants continue stable standard clinical care throughout the trial.
Identical electrode montage (one central target electrode at F3 and four surrounding return electrodes at FP1, Fz, C3, and F7) and the same 40-minute session schedule with 30-second ramp-up and ramp-down periods as the active tACS arms. Sinusoidal current is delivered only during the ramp-up and ramp-down phases. No sustained alternating current is applied for the remainder of the session. All operational procedures, skin preparation, and device appearance are matched to the active arms to maintain masking. Participants continue stable standard clinical care throughout the trial.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 15
The Positive and Negative Syndrome Scale (PANSS) is a clinician-rated instrument used to assess positive symptoms, negative symptoms, and general psychopathology in schizophrenia. The PANSS total score ranges from 30 to 210, with higher scores indicating greater schizophrenia symptom severity. The primary outcome is the change in PANSS total score from baseline to Day 15, compared between the active and sham groups. Change is calculated as the Day 15 total score minus the baseline total score, with negative values indicating improvement.
Time frame: Baseline (Day 0) and Day 15
Change From Baseline in PANSS Total Score at Days 30 and 56
The PANSS total score ranges from 30 to 210, with higher scores indicating greater schizophrenia symptom severity. Change at each visit will be calculated as the visit total score minus the baseline total score. Negative changes indicate improvement. Day 30 and Day 56 will be evaluated separately.
Time frame: Baseline (Day 0), Day 15, Day 30, and Day 56
Change From Baseline in PANSS Positive Subscale Score
The PANSS positive subscale comprises 7 items, each scored from 1 to 7, yielding a total score from 7 to 49. Higher scores indicate more severe positive symptoms. Change at each visit will be calculated as the visit score minus the baseline score; a negative value indicates improvement.
Time frame: Baseline (Day 0), Day 15, Day 30, and Day 56
Change From Baseline in PANSS Negative Subscale Score
The PANSS negative subscale comprises 7 items, each scored from 1 to 7, yielding a total score from 7 to 49. Higher scores indicate more severe negative symptoms. Change at each visit will be calculated as the visit score minus the baseline score; a negative value indicates improvement.
Time frame: Baseline (Day 0), Day 15, Day 30, and Day 56
Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Total Score
The AHRS assesses the severity of auditory hallucinations across seven dimensions. As specified in the protocol, the total score ranges from 0 to 41, with higher scores indicating more severe auditory hallucinations. Change at each visit will be calculated as the visit total score minus the baseline total score; a negative value indicates improvement.
Time frame: Baseline (Day 0), Day 15, Day 30, and Day 56
Change From Baseline in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score
The HAMD-17 is a 17-item clinician-rated measure of depressive symptom severity. Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. Changes from baseline to Days 7, 15, and 45 will be compared between the active TI and sham groups. Change is calculated as the total score at each follow-up visit minus the baseline total score, with negative values indicating improvement.
Time frame: Baseline (Day 0), Day 15, Day 30, and Day 56
Changes From Baseline in low-frequency fluctuation (ALFF) of resting-state functional MRI (rs-fMRI) metrics
Changes in resting-state brain functional measure, amplitude of low-frequency fluctuation (ALFF). Comparisons will be made between active tACS arms and the sham arm, along with associations between imaging changes and symptom improvement .
Time frame: Baseline (Day 0), Day 15, and Day 56
Changes From Baseline in regional homogeneity (ReHo) of resting-state functional MRI (rs-fMRI) metrics
Changes in resting-state brain functional measure, regional homogeneity (ReHo). Comparisons will be made between active tACS arms and the sham arm, along with associations between imaging changes and symptom improvement .
Time frame: Baseline (Day 0), Day 15, and Day 56
Changes From Baseline in functional connectivity of resting-state functional MRI (rs-fMRI) metrics
Changes in resting-state brain functional measure, functional connectivity (FC) within predefined regions of interest. Comparisons will be made between active tACS arms and the sham arm, along with associations between imaging changes and symptom improvement .
Time frame: Baseline (Day 0), Day 15, and Day 56
Plan to share: No
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Start is estimated for Dec 2026; primary completion for Nov 2028, 22 months later.
Of 755 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 22 months is below that.
Counting every sponsor, half of 768 studies reached it within 33 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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