NCT03080194 is a Phase 4 clinical trial of paliperidone palmitate in Schizophrenia, sponsored by Maosheng Fang.

Who is sponsoring NCT03080194?

NCT03080194 is sponsored by Maosheng Fang.

What drugs are being tested in NCT03080194?

Interventions in NCT03080194: paliperidone palmitate, control group.

What condition does NCT03080194 study?

NCT03080194 studies Schizophrenia.

Is NCT03080194 still recruiting?

NCT03080194 is currently status unknown. Last updated 22 April 2017.

Last reviewed 2017-04-22 · How we verify

NCT03080194

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 4 Last updated 22 April 2017

What this trial tests

Phase 4 trial testing paliperidone palmitate in Schizophrenia in 150 participants. Status unknown.

Timeline

1 April 2017

Primary endpoint
1 April 2018

1 April 2018

Quick facts

Lead sponsor	Maosheng Fang
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	1 April 2017
Primary completion	1 April 2018
Estimated completion	1 April 2018

Drugs / interventions tested

paliperidone palmitate (PALIPERIDONE PALMITATE) — full drug profile →
control group — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

Maosheng Fang

Who can join

Adults 18 to 60, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own 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. 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03080194 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Maosheng Fang
Last refreshed: 22 April 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03080194.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing