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Trial record 9 of 92 for:    Not yet recruiting Studies | schizophrenia

The Effect of a Community-based LAI-treated Management Model on the Violence Risk of Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT03080194
Recruitment Status : Not yet recruiting
First Posted : March 15, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Maosheng Fang, Huazhong University of Science and Technology

Brief Summary:

This is a 12-month open-label randomized controlled study. Patients with schizophrenia and violence risk under the government supervision will be enrolled in the study. A community-based long-acting antipsychotics-treated management model will be applied to the experimental group, which means that professional psychiatrists will provide guidance to primary-level mental health workers on the psychotic treatment, and monthly-injected long-acting antipsychotic, paliperidone palmitate, will be used in the schizophrenia treatment. Every subject in experimental group will be equipped with an intelligent robot capable at push-to-talk and push-to-view, allowing the patients and caregivers to contact doctors for assistance at any time.

The subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement.

Subjects in control group will be treated with oral antipsychotics or other conventional medication.


Condition or disease Intervention/treatment Phase
Schizophrenia Drug: paliperidone palmitate Drug: control group Phase 4

Detailed Description:

This is a 12-month open-label randomized controlled study. Patients with schizophrenia and violence risk under the government supervision will be enrolled in the study. A community-based long-acting antipsychotics-treated management model will be applied to the experimental group, which means that professional psychiatrists will provide guidance to primary-level mental health workers on the psychotic treatment, and monthly-injected long-acting antipsychotic, paliperidone palmitate, will be used in the schizophrenia treatment. Every subject in experimental group will be equipped with an intelligent robot capable at push-to-talk and push-to-view, allowing the patients and caregivers to contact doctors for assistance at any time, if they are able to use smart phones.

The subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement. Previous oral antipsychotics could be continued or withdrawn in 2-4 weeks after first paliperidone palmitate administration according to doctors' clinical judgement. Doctors have rights to decide whether a patient needs in-hospital treatment or extramural hospital treatment. The study protocol does not limit other medication or treatment measures except the injectable paliperidone palmitate. Other medication or treatment measures should be decided according to doctors' clinical judgement and negotiation with patients and guardians.

Subjects in control group will be treated with oral antipsychotics or other conventional medication.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of a Community-based Long-acting Antipsychotic-treated Management Model on the Violence Risk of Patients With Schizophrenia: a 1-year, Open-label Randomized Controlled Study
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: paliperidone palmitate group
The subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement.
Drug: paliperidone palmitate
Subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement. Previous oral antipsychotics could be continued or withdrawn in 2-4 weeks after first paliperidone palmitate administration according to doctors' clinical judgement.
Other Name: Sustenna

Active Comparator: control group
The subjects in control group will be applied with oral antipsychotics or other conventional medication.
Drug: control group
Subject in control group will be applied with oral antipsychotics or other conventional medication.




Primary Outcome Measures :
  1. Violence Risk Assessment For Severe Psychiatric Patients [ Time Frame: 1 year ]
    The percentage of subjects rated as no or low risk (scored 0 or 1) in Violence Risk Assessment For Severe Psychiatric Patients after 1-year treatment


Secondary Outcome Measures :
  1. Modified Overt Aggression Scale (MOAS) [ Time Frame: 1 year ]
    Patients' rated score in Modified Overt Aggression Scale after 1-year treatment

  2. Health economic evaluation [ Time Frame: 1 year ]
    The patients' and the caregivers' health economic questionnaire after 1-year treatment

  3. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 1 year ]
    PANSS total score after 6-month and 1-year treatment

  4. Hospitalization frequency [ Time Frame: 1 year ]
    Hospitalization frequency after 6-month and 1-year treatment

  5. WHO Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: 1 year ]
    The patients' and the caregivers' WHOQOL-BREF score after 6-month and 1-year treatment

  6. Visual Analogue Scale-100 (VAS 100) [ Time Frame: 1 year ]
    The patients' and the caregivers' VAS 100 score after 6-month and 1-year treatment

  7. Family Burden Scale of Diseases (FBS) [ Time Frame: 1 year ]
    Family burden of the patient's family

  8. Personal and Social Performance Scale (PSP) [ Time Frame: 1 year ]
    PSP global score after 6-month and 1-year treatment

  9. Treatment Emergent Symptom Scale (TESS) [ Time Frame: 1 year ]
    Treatment Emergent Symptom Scale (TESS) score after 6-month and 1-year treatment

  10. Vital signs [ Time Frame: 1 year ]
    Heart rate and blood pressure after 6-month and 1-year treatment

  11. Clinical laboratory examination [ Time Frame: 1 year ]
    Blood routine examination after 6-month and 1-year treatment

  12. Electrocardiogram (ECG) [ Time Frame: 1 year ]
    Electrocardiogram (ECG) after 6-month and 1-year treatment

  13. Adverse events [ Time Frame: 1 year ]
    The frequency of adverse events in the treatment period



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:

  • Diagnosed as schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-V) and rated under 70 in PANSS;
  • Had violent behavior such as smashing or breaking, threatening with a weapon, commiting arson or explosion in the past one year, whether the behavior can be stopped by persuading or not;
  • Living with a guardian or a caregiver;
  • Informed consent from the patients or their guardians;
  • Resulted negative in urine pregnancy test if female at their reproductive age; female subjects must take effective measures to prevent pregnancy during the whole study or have been postmenopausal.

Exclusion Criteria:

  • Patients who have had suicidal ideation or suicidal attempts within 12 months before screening or in screening period;
  • Intravenous drug abuse or Opioid dependence within 3 months before screening;
  • Patients with treatment-resistant schizophrenia;
  • Large dose of Clozapine (≥200mg/day) or other long-acting injectable antipsychotics used within 3 months or within 2 drug half-life periods before screening;
  • Patients with any severe or unstable cardiovascular, respiratory, nervous system or other system diseases; clinically significant abnormality in laboratory examinations or ECG;
  • Communication difficulties caused by cognitive impairment or unable to complete the assessments in the study;
  • Patients assessed as unsuitable for the study in other reasons, such as allergic or intolerant to risperidone or paliperidone, resistant to risperidone or paliperidone (ineffective after adequate dosage and duration in medical history); unable to provide informed consent; historical treatments which might effect the results of the study; historical neuroleptic malignant syndrome or tardive dyskinesia.

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): NCT03080194


Contacts
Contact: Yi Lee, Doctor (+86)027-59372200 psylee@163.com
Contact: Yang Zhou, Doctor (+86)027-85836687 wuhanzhouyang777@qq.com

Sponsors and Collaborators
Maosheng Fang
Investigators
Study Director: Yi Lee, Doctor Wuhan Mental Health Center

Responsible Party: Maosheng Fang, Research clinician, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03080194     History of Changes
Other Study ID Numbers: WG17A001
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Maosheng Fang, Huazhong University of Science and Technology:
schizophrenia
violence risk
long-acting antipsychotics
community-based

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Paliperidone Palmitate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents