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NCT02366897
Extrapyramidal Side-Effects in Antipsychotic Drug Therapeutics
NA trial testing Manus Sensor Pen in Drug-induced Extrapyramidal Side Effects in 21 participants. Completed in 30 June 2018.
30 June 2018
Quick facts
| Lead sponsor | University of Edinburgh |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 21 |
| Start date | 21 February 2017 |
| Primary completion | 30 June 2018 |
| Estimated completion | 30 June 2018 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Manus Sensor Pen
Conditions studied
- Drug-induced Extrapyramidal Side Effects — all drugs for Drug-induced Extrapyramidal Side Effects →
Sponsor
University of Edinburgh
Who can join
Adults 18 to 50, any sex, with Drug-induced Extrapyramidal Side Effects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02366897
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02366897 (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 University of Edinburgh
- Last refreshed: 21 June 2024
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/NCT02366897.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing