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Trial record 1 of 90 for:    schizophrenia | Not yet recruiting
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The Optimal Treatment for Treatment-resistant Schizophrenia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by Shanghai Mental Health Center
Sponsor:
Information provided by (Responsible Party):
Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT02926976
First received: October 5, 2016
Last updated: NA
Last verified: October 2016
History: No changes posted
  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 Blind (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 5, 2016
Last Updated: October 5, 2016
Individual Participant Data  
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

ClinicalTrials.gov processed this record on April 27, 2017