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Trial record 7 of 91 for:    Not yet recruiting Studies | schizophrenia

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

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ClinicalTrials.gov Identifier: NCT03434210
Recruitment Status : Not yet recruiting
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Yi Li MD, PhD, Huazhong University of Science and Technology

Brief Summary:
This is a 49 weeks open-label randomized controlled study. Patients with schizophrenia and violence risk 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. Subjects in control group will be treated and cared as usual.

Condition or disease Intervention/treatment Phase
Schizophrenia Other: LAT-treated Community Model Other: care as usual Not Applicable

Detailed Description:
This is a 49 weeks open-label,cluster 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. 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 per clinical judgement. For subjects who did not take risperidone, paliperidone extended release tablets, risperidone microspheres or paliperidone palmitate for injection previously, subjects should take oral paliperidone or risperidone sustained release tablets in the screening phase to perform ultra-sensitive test (the minimum dose of risperidone 1 mg/day and the minimum dose of sustained-release tablets paliperidone 3 mg/day, at least orally three days). Only subjects who were judged by the treating physician as tolerance to the drug could usepaliperidone palmitate .Suggest previous antipsychotics could be withdrawn within 4 weeks after first paliperidone palmitate administration , but will follow doctors' clinical judgement. The study protocol does not limit other medication or treatment measures except the injectable paliperidone palmitate. Other medication or treatment measures should be decided by doctors' clinical judgement and align with patients and caregivers.Subjects in control group will be treated and cared as usual.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor would not known the arm, and forbiden to ask and comminicate with patients about the intervention.
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 49 Weeks, Open-label Cluster Randomized Controlled Study
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LAT-treated Community Model
The subjects in experimental group are on 'LAT-treated Community Model'. which means,beside care as usual, subjects will be treated by paliperidone palmitate, Psychiatrists will guide community mental health professinals about the treatment and management. Psychiatrists will give community mental health professinals and patients/ caregiver long acting injection related education information.
Other: LAT-treated Community Model
The subjects in experimental group is on 'LAT-treated Community Model'. which means,beside care as usual, subjects will be treated by paliperidone palmitate, Psychiatrists will guide community mental health professinals about the treatment and management. Psychiatrists will give community mental health professinals and patients/ caregiver long acting injection related education information.

Care as usual
The subjects in control group are on " cared as usual" Which means Patients will be managed follow the request of National Continuing Management and Intervention Program for Psychoses. Patients will managed by community mental health professionals, get education information and rehablitation guidence from them.
Other: care as usual
Control group will get usual community care, the treatment is identified by doctors, patients and care-giver as usual.
Other Name: Control group




Primary Outcome Measures :
  1. Violence Risk Assessment For Psychiatric Patients [ Time Frame: 49 Weeks ]
    The percentage of subjects rated as no or low risk (scored 0 or 1) in Violence Risk Assessment For Severe Psychiatric Patients during 49 weeks treatment

  2. Modified Overt Aggression Scale (MOAS) [ Time Frame: 49 Weeks ]
    Score change of Modified Overt Aggression Scale (MOAS ). MOAS is used to assess aggressive behavior of psychosis patients. Including Verbal aggressive, aggressive to property, aggressive to self, aggressive to others, and total score. Each domain with score 0 to 4, total weighted score 0 to 40


Secondary Outcome Measures :
  1. Health economic evaluation [ Time Frame: 49 Weeks ]
    Self developed health economic questionnaire, including demography questions, income before and after schizophrenia onset, schizophrenia related direct and indirect cost

  2. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 49 Weeks ]
    PANSS score change. PANSS was used to assess schizophrenia psychopathology symptoms of subjects. PANSS gave a total score (total score of 30 items) and three subscale scores, positive subscale (7 items), negative subscale (7 items), general psychopathology symptoms subscale (16 items) . Each scale rated from 1 (none) to 7 (very heavy).

  3. Hospitalization frequency [ Time Frame: 49 Weeks ]
    Hospitalization due to schizophrenia during 49 weeks

  4. WHO Quality of Life-BREF (WHOQOL-BREF) of patients [ Time Frame: 49 Weeks ]
    The patients' WHOQOL-BREF score. The WHOQOL-BREF offers a short, generic, subjective quality of life (QoL) measure, 26 important questions are scored in environmental, social, physical and psychological domains, each question from 1-5.

  5. WHO Quality of Life-BREF (WHOQOL-BREF) of caregiver [ Time Frame: 49 Weeks ]
    The caregivers' WHOQOL-BREF score. WHOQOL-BREF offers a short, generic, subjective quality of life (QoL) measure, 26 important questions are scored in environmental, social, physical and psychological domains, each question from 1-5.

  6. Visual Analogue Scale-100 (VAS 100) of patients treatment satisfication [ Time Frame: 49 weeks ]
    The patients' VAS 100 score change. Patients rate according to their treatment satisfication, score from 1( extremely unsatisfied) to 100( extremely satisfied.

  7. Visual Analogue Scale-100 (VAS 100) of caregiver's treatment satisfication [ Time Frame: 49 weeks ]
    The caregivers' VAS 100 score change.Caregivers rate according to their treatment satisfication, score from 1( extremely unsatisfied) to 100( extremely satisfied.

  8. Family Burden Scale of Diseases (FBS) [ Time Frame: 49 Weeks ]
    Family burden of the patient's family. Including 26 items, score 0( no burden) to 2(heavy burden). Refer to family economy, family daily activities, family entertainment activities, family relationships, family member physical health and mental health.

  9. Personal and Social Performance Scale (PSP) [ Time Frame: 49 Weeks ]
    PSP was a clinical scoring tool that was used for personal and social function assessment in schizophrenia subjects, and the score ranged between 1 and 100. The scale defined a continuous functional status, from overall function impaired (completely lack of independent basic functions, survival is significantly dangerous) to function well. The scale takes four functional dimensions into account: a) social useful activities, including work and study, b) the relationship between the individual and society, c) self-care, and d) disturbing and aggression

  10. Treatment Emergent Symptom Scale (TESS) [ Time Frame: 49 Weeks ]
    Treatment Emergent Symptom Scale (TESS) is a checklist including common adverse event in psychotic treatment. each item rate from 0( no) to 4 (heavy)

  11. Clinical laboratory examination [ Time Frame: 49 weeks ]
    Blood routine examination

  12. Electrocardiogram (ECG) [ Time Frame: 49 Weeks ]
    ECG testing should be performed in a quiet non-interference (such as TV, mobile) environment for the subjects. Before testing ECG the subjects should rest in the supine position for at least 5 minutes and should be limited to conversation or physical activity. Twelve-lead ECG was recorded by 25 mm/sec paper speed, measuring RR, PR, QRS and QT intervals.

  13. Adverse events [ Time Frame: 49 weeks ]
    The frequency of adverse events in the treatment period



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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)
  • Had violent behavior such as smashing or breaking, threatening with a weapon, committing 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): NCT03434210


Contacts
Contact: Yi Li, Doctor (+86)027-59372200 psylee@163.com
Contact: BaoLiang Zhong, Doctor (+86)027-85836687

Sponsors and Collaborators
Yi Li MD, PhD
Investigators
Study Director: Yi Li, Doctor Wuhan Mental Health Center

Responsible Party: Yi Li MD, PhD, Research clinician, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03434210     History of Changes
Other Study ID Numbers: WG17A002
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018

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

Keywords provided by Yi Li MD, PhD, 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