NCT07398365

Medical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This observational study will characterise the general psychiatric and general medical phenotypes of 100 adults, sequentially admitted to NHS General Adult Psychiatry (GAP) "mental health" inpatient wards, providing the first detailed information on morbidity in this patient population.

Detailed description

It is often supposed that most patients who attend secondary care General Adult Psychiatry (GAP) services would be excluded from clinical trials because they have too many co-morbidities, they are 'treatment resistant' (have a condition that does not improve despite trying two or more standard treatments), and their conditions are too severe. Hence, it would be helpful to properly measure these variables in GAP patients using questionnaires and a review of the case notes to see how many GAP patients would indeed be excluded from clinical trials. It is anticipated that this will show that the participants in clinical trials are very different from 'real life' GAP patients, and that could explain why some promising results from clinical trials do not translate into useful new treatments. Also, this data could act as a benchmark or baseline against which to measure the efficacy of novel treatments and interventions. PRIMARY OBJECTIVE Using the most commonly employed diagnostic tools, severity rating scales, and a systematic review of the case notes, the typical characteristics of GAP patients will be described. SECONDARY OBJECTIVES The above data will be used to compared 'typical/real life' patients with the participants in impactful clinical trials. This is a cross sectional quantitative study. Participants will spend about an hour attending to the questionnaires and talking to their clinician. STUDY SETTING The study will take place in St John's Hospital, Livingston, West Lothian, on the acute psychiatric ward, and the outpatient department. STUDY POPULATION 100 patients who attend the West Lothian NHS GAP service will be consecutively recruited. These participants will be between 18 and 65 years old and suffering from mental disorders that their GP could not treat. IDENTIFYING PARTICIPANTS The usual clinical team will ask eligible patients if they would like to participate. CONSENTING PARTICIPANTS Consent will be thoroughly informed by an information leaflet and subsequent discussion with the involved clinician. Participants will take the information leaflet away with them and express their consent, or not, in their own time by using the contact details on the information leaflet, or when they next see their clinician. WITHDRAWAL OF STUDY PARTICIPANTS Participants will have the option of withdrawal from all aspects of the trial, but the data collected up to that point could be used. To safeguard rights, the minimum personally identifiable information possible will be collected. There are no stopping rules. Participants could withdraw at any time.

Conditions

• Bipolar Affective Disorder
• Schizophrenia Disorders
• Depression Disorders
• Personality Disorders

Interventions

Type	Name	Description
OTHER	Questionnaires, rating scales, & review of notes	Observational - questionnaires, rating scales, \& review of notes

Timeline

• Start date: 2024-04-03
• Primary completion: 2026-04-03
• Completion: 2026-08-08
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: United Kingdom