Sequential Treatment Approaches for Treatment-Resistant Schizophrenia
NCT07918222, Phase 3, Recruiting, Shanghai Mental Health Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Sequential Treatment Approaches for Treatment-Resistant Schizophrenia | ClinicalTrials.gov |
| NCT number | NCT07918222 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 300 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Shanghai Mental Health Center | ClinicalTrials.gov |
| Conditions | Treatment-resistant Schizophrenia | ClinicalTrials.gov |
| Interventions | [Phase 1] Clozapine, [Phase 1] Aripiprazole, [Phase 1] Amisulpride, [Phase 2] Modified Electroconvulsive Therapy (MECT), [Phase 2] Magnetic Seizure Therapy (MST) | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | PANSS reduction rate at Week 8 during the pharmacological optimization phase | Baseline of pharmacological optimization phase and Week 8 | Percentage reduction in Positive and Negative Syndrome Scale total score from baseline to Week 8. The PANSS scale consists of 30 items, and each item is rated on a 7-point scale, ranging from 1 (no symptoms) to 7 (extremely severe). The PANSS reduction rate is calculated as: (baseline PANSS total score - Week 8 PANSS total score) / (baseline PANSS total score - 30) × 100%. | ClinicalTrials.gov |
| Primary | PANSS reduction rate at Week 4 during the neuromodulation phase | Baseline of neuromodulation phase and Week 4 | Percentage reduction in PANSS total score from baseline of the neuromodulation phase to Week 4. The PANSS scale consists of 30 items, and each item is rated on a 7-point scale, ranging from 1 (no symptoms) to 7 (extremely severe). The PANSS reduction rate is calculated as: (baseline PANSS total score - Week 4 PANSS total score) / (baseline PANSS total score - 30) × 100%. | ClinicalTrials.gov |
| Secondary | Change in CGI-S score | Pharmacological optimization: baseline and Week 8; Neuromodulation: baseline and Week 4. | Change in Clinical Global Impression-Severity (CGI-S) score from baseline to the end of assigned treatment. The scale provides an assessment of both disease severity and overall efficacy.The severity of the disease was scored on an eight-point scale ranging from 0 (not rated) to 7 (extremely severe). The overall efficacy was assessed on an 8-point scale ranging from 0 (not assessed) to 7 (significant deterioration). | ClinicalTrials.gov |
| Secondary | Trajectory of PANSS total score improvement during the neuromodulation phase | Baseline of the neuromodulation phase and weekly during the 4-week neuromodulation treatment course | Rate of change in Positive and Negative Syndrome Scale total score during the 4-week neuromodulation treatment course. The PANSS scale consists of 30 items, and each item is rated on a 7-point scale, ranging from 1 (no symptoms) to 7 (extremely severe). Repeated PANSS assessments will be used to compare the trajectory and speed of symptom improvement between the MECT and MST groups. | ClinicalTrials.gov |
| Secondary | Change in AMT specificity score during the neuromodulation phase | Baseline of the neuromodulation phase and Week 4 | Change in Autobiographical Memory Test(AMT) specificity score from baseline of the neuromodulation phase to Week 4. The AMT specificity score is defined as the number of specific autobiographical memories retrieved in response to 12 cue words, with scores ranging from 0 to 12 and higher scores indicating better autobiographical memory specificity. Change is calculated as Week 4 AMT specificity score minus baseline AMT specificity score; negative values indicate decline in autobiographical memory specificity. | ClinicalTrials.gov |
| Secondary | Change from baseline in cognitive function: MCCB | Baseline, Month 1, and Month 2 during the pharmacological optimization phase; and Week 4 of the neuromodulation phase. | MATRICS consensus cognitive battery (MCCB) consists of 10 tests that assess cognitive performance in 7 domains, including processing speed, attention/vigilance, working memory, verbal memory, visual learning, reasoning and problem solving, and social cognition.The MCCB T-score is calculated based on a Chinese community sample, with a normative mean of 50 and a standard deviation of 10. Higher scores indicate a better neurocognitive outcome. | ClinicalTrials.gov |
| Secondary | Change in visuospatial working memory during the neuromodulation phase | Baseline of the neuromodulation phase and weekly during the 4-week neuromodulation phase | Change in visuospatial working memory from baseline to Week 4, assessed using the Wechsler Memory Scale-III Spatial Span subtest (WMS III). The WMS III total score ranges from 0 to 32, with higher scores indicating better visuospatial working memory performance. | ClinicalTrials.gov |
| Secondary | Change in visual learning during the neuromodulation phase | Baseline of the neuromodulation phase and weekly during the 4-week neuromodulation phase | Change in visual learning from baseline to Week 4, assessed using the Brief Visuospatial Memory Test-Revised (BVMT-R).The BVMT-R total recall score ranges from 0 to 36, where higher scores indicate better visual learning ability. | ClinicalTrials.gov |
| Secondary | Change in personal and social functioning | Baseline, Week 8 of the pharmacological optimization phase and Week 4 of the neuromodulation phase | Change in Personal and Social Performance Scale(PSP) score from baseline to the end of the corresponding treatment phase.The PSP score ranges from 0 to 100, where higher scores indicate better personal and social functioning. | ClinicalTrials.gov |
| Secondary | Extrapyramidal adverse effects: The Barnes Akathisia Scale (BAS) | Baseline, Week 4, Week 8 during the pharmacological optimization phase and Week 1, Week 2, Week 3, Week 4 during the neuromodulation phase | The Barnes Akathisia Scale (BAS) will be used to evaluate objective performance and subjective experience of akathisia, scored from 0 to 3, and the overall clinical evaluation of akathisia is scored from 0 to 5. The higher scores mean a more serious side effect. | ClinicalTrials.gov |
| Secondary | Extrapyramidal adverse effects: Simpson-Angus Extrapyramidal Side Effects Scale (SAS) | Baseline, Week 4, Week 8 during the pharmacological optimization phase and Week 1, Week 2, Week 3, Week 4 during the neuromodulation phase | Simpson-Angus Extrapyramidal Side Effects Scale (SAS) consists of 10 items, each scored from 0 to 4. The higher scores mean a more serious side effect. | ClinicalTrials.gov |
| Secondary | Extrapyramidal adverse effects: Abnormal Involuntary Movement Scale (AIMS) | Baseline, Week 4, Week 8 during the pharmacological optimization phase and Week 1, Week 2, Week 3, Week 4 during the neuromodulation phase | Abnormal Involuntary Movement Scale (AIMS) consists of 12 items. The first 10 of 12 items is scored from 0 to 4, and the last 2 is scored from 0 to 1. The higher scores mean the more obvious abnormal involuntary movement. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)