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The Optimal Treatment for Treatment-resistant Schizophrenia

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ClinicalTrials.gov Identifier: NCT02926976
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Mental Health Center

Brief Summary:
The Optimal Treatment for Treatment-resistant Schizophrenia

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Risperidone with Clozapine Drug: Aripiprazole with Clozapine Drug: sodium valproate with Clozapine Device: modified electroconvulsive therapy(MECT) with Clozapine Device: Magnetic seizure therapy(MST) with Clozapine Device: clozapine Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Optimal Treatment for Treatment-resistant Schizophrenia
Study Start Date : November 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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
Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
Other Name: Risperidone Tablet

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

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

Active Comparator: clozapine
only clozapine, dosage and frequency:300~600 mg/d;
Device: clozapine
clozapine may be used in the treatment of treatment-resistant schizophrenia

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

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




Primary Outcome Measures :
  1. Change from baseline in Positive and Negative Syndrome Scale [PANSS] [ Time Frame: At baseline, 4th week, 8th week,12th week ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926976


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

Locations
China
DTliu Recruiting
Shanghai, China
Contact: DT Liu, PHD       erliu110@126.com   
Sponsors and Collaborators
Shanghai Mental Health Center

Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT02926976     History of Changes
Other Study ID Numbers: The optimal treatment for TRS
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shanghai Mental Health Center:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Clozapine
Aripiprazole
Valproic Acid
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Anticonvulsants
Enzyme Inhibitors
GABA Agents
Antimanic Agents
GABA Antagonists