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Extrapyramidal Side-Effects in Antipsychotic Drug Therapeutics

NCT02366897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-06-21

No results posted yet for this study

Summary

The project is aimed at addressing the fundamental issue in antipsychotic therapeutics -the balance between mental state benefits and neurological risks.The latter cannot be overestimated and clinical skills in themselves are inadequately sensitive to refine practice. With all current and "pipeline" antipsychotics based on central dopamine blockade, there is little prospect that therapeutics can be improved by advances in pharmacology alone.

The project uses, for the first time, technology that is not only simple, real-life and user-friendly but "modern" and socially held in high regards. The proposal depends on patients receiving antipsychotic medication where clinically indicated. At all times, subjects will receive clinically-indicated therapy. The major ethical issue will relate to the issue of informed consent in those suffering from major psychiatric disorder. This is a routine consideration in psychiatric practice and the investigators will seek guidance on this from the Consultant Psychiatrist responsible for potential participants and would not proceed with initial approaches in cases of doubt or absence of capacity.

This is a pilot/feasibility study with no intention to utilise the data for commercialisation of the device or to expand the CE (Conformité Européenne) marking.

Conditions

  • Drug-induced Extrapyramidal Side Effects

Interventions

DEVICE

Manus Sensor Pen

Manus Sensor Pen as made by Manus Neurodynamica Ltd

Sponsors & Collaborators

  • University of Edinburgh

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-21
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02366897 on ClinicalTrials.gov