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The Optimal Treatment for Treatment-resistant Schizophrenia

This study is not yet open for participant recruitment.
Verified October 2016 by Shanghai Mental Health Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02926976
First Posted: October 6, 2016
Last Update Posted: October 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shanghai Mental Health Center
  Purpose
The Optimal Treatment for Treatment-resistant Schizophrenia

Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Optimal Treatment for Treatment-resistant Schizophrenia

Resource links provided by NLM:


Further study details as provided by Shanghai Mental Health Center:

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

Secondary Outcome Measures:
  • Change from baseline in clinical global impression [CGI] [ Time Frame: At baseline, 4th week, 8th week,12th week ]
  • Change from baseline in Simpson-Angus Scale [SAS] [ Time Frame: At baseline, 4th week, 8th week,12th week ]
  • Change from baseline in Abnormal Involuntary Movement Scale[AIMS] [ Time Frame: At baseline, 4th week, 8th week,12th week ]

Estimated Enrollment: 150
Study Start Date: November 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: risperidone with clozapine
risperidone; dosage form: 1 mg; dosage and frequency:2.0~6.0 mg/d; duration: 3 months.
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:10~30 mg/day; duration: 3 months.
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:500~1000 mg/day; 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: Modified electroconvulsive therapy with clozapine
10 times MECT for 4 weeks.
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.
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

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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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

Sponsors and Collaborators
Shanghai Mental Health Center
  More Information

Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT02926976     History of Changes
Other Study ID Numbers: The optimal treatment for TRS
First Submitted: October 5, 2016
First Posted: October 6, 2016
Last Update Posted: October 6, 2016
Last Verified: October 2016
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