CompletedPhase 4

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

China145 participantsStarted 2018-09-06

Plain-language 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).

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Positive and Negative Syndrome Scale (PANSS)

Timeframe: the baseline

Positive and Negative Syndrome Scale (PANSS)

Timeframe: the end of the six week

Positive and Negative Syndrome Scale (PANSS)

Timeframe: the end of the twelve week

Scale for the Assessment of Negative Symptoms (SANS)

Timeframe: the baseline

Scale for the Assessment of Negative Symptoms (SANS)

Timeframe: the end of the six week

Scale for the Assessment of Negative Symptoms (SANS)

Timeframe: the end of the twelve week

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Timeframe: the baseline

Trial details

NCT IDNCT03652974

SponsorShanghai Mental Health Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-30

View on ClinicalTrials.gov More Schizophrenia trials

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Positive and Negative Syndrome Scale (PANSS)

Timeframe: the baseline

Positive and Negative Syndrome Scale (PANSS)

Timeframe: the end of the six week

Positive and Negative Syndrome Scale (PANSS)

Timeframe: the end of the twelve week

Scale for the Assessment of Negative Symptoms (SANS)

Timeframe: the baseline

Scale for the Assessment of Negative Symptoms (SANS)

Timeframe: the end of the six week

Scale for the Assessment of Negative Symptoms (SANS)

Timeframe: the end of the twelve week

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Timeframe: the baseline