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

• Status: Completed
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Mental Health Center
• Treatments: Amisulpride; Clozapine; Valproic Acid

Criteria

Inclusion Criteria:

• The diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)

• 18～60 years old

• Clozapine resistance was defined as used at least two antipsychotics with different chemical structures with appropriate dosages for a sufficient duration, and recently have received stable dose of clozapine 400 mg or more per day for at least 6 months.

• Signed an informed consent

Exclusion Criteria:

• Patients to be diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for substance abused, development delayed

• Suffering from serious physical disease and can not accept the treatment

• Allergic to sodium valproate, amisulpride, propofol, succinylcholine or atropine

• Participated in any clinical subject within 30 days

• Pregnancy or lactation

• Inability to sign informed consent because of capacity due due to severe mental illness, significant psychomotor agitation or slowness test completion