CClinicalTrials.gg
Status unknownNCT02926976Updated Mar 13, 2019

The Optimal Treatment for Treatment-resistant Schizophrenia

An interventional study of Risperidone with Clozapine and Aripiprazole with Clozapine in Schizophrenia, sponsored by Shanghai Mental Health Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-03-13.

Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The Optimal Treatment for Treatment-resistant Schizophrenia

Read the detailed description

To explore the curative effect and safety of Risperidone,aripiprazole,sodium valproate,modified electroconvulsive therapy(MECT), or Magnetic seizure therapy(MST) with Clozapine in the treatment of treatment-resistant schizophrenia, and to provide the basis for clinical medication.

02

Conditions studied

  • Schizophrenia

Keywords

  • Schizophrenia
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 150 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The diagnosis of schizophrenia according to DSM-V
  • 18~60 years old
  • 2 prior failed treatment trials with 2 different antipsychotics at doses of at least 600 mg/day chlorpromazine equivalents, each of at least 6 weeks duration;
  • Signed an informed consent

Exclusion criteria

Exclusion Criteria:

  • patients to be diagnosed according to DSM-V for substance abused, development delayed
  • suffering from serious physical disease and can not accept the treatment
  • MST contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure
  • allergic to risperidone ,aripiprazole, or sodium valproate
  • Participated in any clinical subject within 30 days
  • Pregnancy or lactation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    risperidone with clozapine

    risperidone, dosage form: 1 mg, dosage and frequency:3.0\~6.0 mg/d; clozapine, dosage and frequency:300\~600 mg/d; duration: 8 weeks

    Drug: Risperidone with Clozapine

  • Active comparator
    aripiprazole with clozapine

    aripiprazole, dosage form: 5 mg, dosage and frequency:15\~30 mg/day; clozapine, dosage and frequency:300\~600 mg/d; duration: 8 weeks

    Drug: Aripiprazole with Clozapine

  • Active comparator
    sodium valproate with clozapine

    sodium valproate, dosage form: 250 mg, dosage and frequency:600\~1200 mg/day; clozapine, dosage and frequency:300\~600 mg/d; duration: 3 months.

    Drug: sodium valproate with Clozapine

  • Active comparator
    clozapine

    only clozapine, dosage and frequency:300\~600 mg/d;

    Device: clozapine

  • Active comparator
    Modified electroconvulsive therapy with clozapine

    10 times MECT for 4 weeks, if the PANSS reductive ratio is less 20% in the end of 8th week by the using of risperidone with clozapine, aripiprazole with clozapine, sodium valproate with clozapine, or clozapine.

    Device: modified electroconvulsive therapy(MECT) with Clozapine

  • Active comparator
    Magnetic seizure therapy with clozapine

    10 times MST for 4 weeks, if the PANSS reductive ratio is less 20% in the end of 8th week by the using of risperidone with clozapine, aripiprazole with clozapine, sodium valproate with clozapine, or clozapine.

    Device: Magnetic seizure therapy(MST) with Clozapine

Interventions

  • DrugRisperidone with Clozapine

    Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia

    Also known as: Risperidone Tablet

  • DrugAripiprazole with Clozapine

    Aripiprazole may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia

    Also known as: Aripiprazole Tablets

  • Drugsodium valproate with Clozapine

    sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia

    Also known as: Valproate

  • Devicemodified electroconvulsive therapy(MECT) with Clozapine

    modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia

  • DeviceMagnetic seizure therapy(MST) with Clozapine

    Magnetic seizure therapy(MST) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia

  • Deviceclozapine

    clozapine may be used in the treatment of treatment-resistant schizophrenia

06

What researchers measure

Primary outcomes

  1. Change from baseline in Positive and Negative Syndrome Scale [PANSS]

    Time frame: At baseline, 4th week, 8th week,12th week

Secondary outcomes

  1. Change from baseline in clinical global impression [CGI]

    Time frame: At baseline, 4th week, 8th week,12th week

  2. Change from baseline in Simpson-Angus Scale [SAS]

    Time frame: At baseline, 4th week, 8th week,12th week

  3. Change from baseline in Abnormal Involuntary Movement Scale[AIMS]

    Time frame: At baseline, 4th week, 8th week,12th week

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02926976
Lead sponsor
Shanghai Mental Health Center
Responsible party
Sponsor
First posted
Oct 6, 2016
Start date
Nov 2016
Primary completion
Sep 2019 (estimated)
Completion
Sep 2019 (estimated)
Last update
Mar 13, 2019

Study contacts

Dengtang Liu
Contact
erliu110@126.com
+86 21 64387250-73775

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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