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NCT Number: NCT07398365

Medical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients

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.

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Key information

Conditions

Bipolar Affective Disorder Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Depression Disorders Mental Disorders Mood Disorders Neoplasms Personal Satisfaction Personality Disorders Psychological Well-Being Psychotic Disorders Respiration Disorders Respiratory Tract Diseases Schizophrenia Schizophrenia Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St John's Hospital

Livingston, West Lothian, EH16 4TJ, United Kingdom

Location status: Recruiting

Location contact

David Hayward

CONTACT

[email protected]

01506523000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Adults aged between 18 and 65 years admitted to GAP wards during recruitment period

Exclusion:

  • Admissions to non-GAP wards (e.g., forensic psychiatry, young people's units, perinatal, old age psychiatry, or general medical wards)

Treatment and study plan

Questionnaires, rating scales, & review of notes

Other

Observational - questionnaires, rating scales, & review of notes

Primary outcomes

  1. Rates of comorbid physical illnesses

    Time frame: At enrolment

    As per medical note review and physical examination - BMI

  2. Psychiatric diagnosis

    Time frame: At enrolment

    ICD-11 codes

  3. Severity of psychosis

    Time frame: At enrolment

    Brief Psychiatric Rating Scale (BPRS) score; 18 to 126, higher scores indicate more severe symptoms

  4. Depression of severity

    Time frame: At enrolment

    Inventory of Depressive Symptomatology Self Report (IDS-SR); 0 to 84, higher scores indicate more severe symptoms

  5. Severity of mania

    Time frame: At enrolment

    Young Mania Rating Scale score; 0 to 60, higher scores indicate more severe symptoms

  6. Severity of anxiety

    Time frame: At enrolment

    General Anxiety Scale (GAD-7) score; 0 to 21, higher scores indicate more severe symptoms

  7. Substance use

    Time frame: At enrolment

    Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool score; tobacco 0 to 3, alcohol 0 to 4, others 0 to 21, higher scores indicate more risky use

  8. Mental Health Act status

    Time frame: At enrolment

    MHA detention status; informal or detained

  9. Treatment resistance indicators

    Time frame: At enrolment

    Clozapine for psychosis, and ECT treatment and Massachusetts General Hospital Staging (MGH-S) score for depression. MGH-S uses the number of failed trials with the intensity/optimization of each trial to produce a score where >3.5 defines treatment resistant depression

  10. Rates of abnormal findings on physical examination

    Time frame: At enrolment

    When psychiatric patients are admitted to hospital, they are examined by a resident doctor, including inspection, auscultation, and palpation. Rates of abnormal findings on cardiovascular , respiratory, abdominal, and neurological examination will be noted..

  11. Abnormal laboratory values

    Time frame: At enrolment

    When psychiatric patients are admitted to hospital, screening blood tests, including full blood count, urea and electrolytes (kidney), liver function tests, random glucose, cholesterol, triglycerides, and thyroid function tests.

  12. Rates of comorbid physical illness

    Time frame: At enrolment

    As per medical note review and physical examination - blood pressure mmHg

  13. Rates of comorbid physical illness

    Time frame: At enrolment

    As per medical note review and physical examination - cardiometabolic disease

  14. Rates of comorbid physical illness

    Time frame: At enrolment

    As per medical note review and physical examination - neurological disease.

  15. Rates of comorbid physical illness

    Time frame: At enrolment

    As per medical note review and physical examination - musculoskeletal disease

  16. Rates of comorbid physical illness

    Time frame: At enrolment

    As per medical note review and physical examination - respiratory disease

  17. Rates of comorbid physical illness

    Time frame: At enrolment

    As per medical note review and physical examination - renal disease

  18. Rates of comorbid physical illness

    Time frame: At enrolment

    As per medical note review and physical examination - hepatic disease

  19. Rates of comorbid physical illness

    Time frame: At enrolment

    As per medical note review and physical examination - haematological disease

Study contacts

Contact information is provided by the study sponsor or research team.

David Hayward

CONTACT

[email protected]

01506 523000

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian
  • University of Dundee

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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