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NCT03652974
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
Phase 4 trial testing sodium valproate with Clozapine in Schizophrenia in 145 participants. Completed in 30 August 2021.
30 August 2021
Quick facts
| Lead sponsor | Shanghai Mental Health Center |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 145 |
| Start date | 6 September 2018 |
| Primary completion | 30 August 2021 |
| Estimated completion | 30 August 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- sodium valproate with Clozapine — full drug profile →
- modified electroconvulsive therapy(MECT) with Clozapine
- amisulpride with Clozapine — full drug profile →
- placebo with Clozapine — full drug profile →
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
Shanghai Mental Health Center — full company profile →
Who can join
Adults 18 to 60, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this study, investigators designed a double-blind randomized trial to compare the efficacy and safety between sodium valproate, amisulpride and MECT combination therapy in clozapine-treated refractory schizophrenia (CTRS).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Amisulpride augmentation therapy improves cognitive performance and psychopathology in clozapine-resistant treatment-refractory schizophrenia: a 12-week randomized, double-blind, placebo-controlled trial.
Zhu MH, Liu ZJ, Hu QY, Yang JY, et al · · 2022 · cited 44× · PMID 36253804 · DOI 10.1186/s40779-022-00420-0 -
Association of cytokines levels, psychopathology and cognition among CR-TRS patients with metabolic syndrome.
Dong Y, Zhu M, Li Y, Liu N, et al · · 2024 · cited 6× · PMID 38627438 · DOI 10.1038/s41537-024-00469-x -
Amisulpride Augmentation Therapy Improves Cognitive Performance and Psychopathology in Clozapine-resistant Treatment-refractory Schizophrenia (CTRS): a 12-week Randomized, Double-blind, Placebo-controlled Trial
Li Z, Zhu M, Liu Z, Hu Q, et al · · 2022 · DOI 10.21203/rs.3.rs-1213529/v1
Verify or expand the search:
- PubMed search for NCT03652974
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Shanghai Mental Health Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03652974 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Mental Health Center
- Last refreshed: 6 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03652974.
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