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NCT03652974

Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy

Completed Phase 4 Last updated 6 September 2022
What this trial tests

Phase 4 trial testing sodium valproate with Clozapine in Schizophrenia in 145 participants. Completed in 30 August 2021.

Timeline
6 September 2018
Primary endpoint
30 August 2021
30 August 2021

Quick facts

Lead sponsorShanghai Mental Health Center
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment145
Start date6 September 2018
Primary completion30 August 2021
Estimated completion30 August 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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:

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

Other Shanghai Mental Health Center trials

Trials by the same sponsor.

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Data sources for this page

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