NCT07398365

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Apr 2024Aug 2026

Study Start

First participant enrolled

April 3, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2026

Expected
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

September 24, 2025

Last Update Submit

May 4, 2026

Conditions

Keywords

General Adult Psychiatrymental healthphysical healthinpatientsschizophreniaNHSBipolar affective disorderdepressionpsychosistreatment resistancepersonality disordercardiometabolic diseasecancerrespiratory disease

Outcome Measures

Primary Outcomes (19)

  • Rates of comorbid physical illnesses

    As per medical note review and physical examination - BMI

    At enrolment

  • Psychiatric diagnosis

    ICD-11 codes

    At enrolment

  • Severity of psychosis

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

    At enrolment

  • Depression of severity

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

    At enrolment

  • Severity of mania

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

    At enrolment

  • Severity of anxiety

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

    At enrolment

  • Substance use

    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

    At enrolment

  • Mental Health Act status

    MHA detention status; informal or detained

    At enrolment

  • Treatment resistance indicators

    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

    At enrolment

  • Rates of abnormal findings on physical examination

    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..

    At enrolment

  • Abnormal laboratory values

    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.

    At enrolment

  • Rates of comorbid physical illness

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

    At enrolment

  • Rates of comorbid physical illness

    As per medical note review and physical examination - cardiometabolic disease

    At enrolment

  • Rates of comorbid physical illness

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

    At enrolment

  • Rates of comorbid physical illness

    As per medical note review and physical examination - musculoskeletal disease

    At enrolment

  • Rates of comorbid physical illness

    As per medical note review and physical examination - respiratory disease

    At enrolment

  • Rates of comorbid physical illness

    As per medical note review and physical examination - renal disease

    At enrolment

  • Rates of comorbid physical illness

    As per medical note review and physical examination - hepatic disease

    At enrolment

  • Rates of comorbid physical illness

    As per medical note review and physical examination - haematological disease

    At enrolment

Study Arms (4)

Group 1 - Schizophrenia Group

* Schizophrenia - 6A20 * Schizoaffective disorder - 6A21 * Delusional disorder - 6A24 * Other primary psychotic disorders (psychosis NOS) - 6A2Z * Schizotypal disorder - 6A23

Other: Questionnaires, rating scales, & review of notes

Group 2 - Bipolar Group

* Bipolar type I disorder, current episode manic - 6A60 • without psychotic symptoms - 6A60.0 • with psychotic symptoms - 6A60.2 * Bipolar type II disorder, current episode depressed, with psychotic symptoms - 6A60.6

Other: Questionnaires, rating scales, & review of notes

Group 3 -Depression Group

* Recurrent depressive disorder, current severe episode without psychotic symptoms - 6A71.3 * Single episode depressive disorder, moderate with psychotic symptoms - 6A70.2 * Recurrent depressive disorder (not otherwise specified) - 6A71 * Mixed depressive and anxiety disorder - 6A73

Other: Questionnaires, rating scales, & review of notes

Group 4 - Personality Group

* Personality disorder - 6D10, 6D10.Z * Complex post-traumatic stress disorder - 6B41 * Substance use disorders - 6C4\* codes (e.g., 6C4G.1 alcohol, 6C45.6 sedative-hypnotic, 6C43.2 cannabis, 6C44.2 stimulants, 6C4Z unspecified)

Other: Questionnaires, rating scales, & review of notes

Interventions

Observational - questionnaires, rating scales, \& review of notes

Group 1 - Schizophrenia GroupGroup 2 - Bipolar GroupGroup 3 -Depression GroupGroup 4 - Personality Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults (≥18 years) consecutively admitted to NHS GAP inpatient wards in Scotland.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St John's Hospital

Livingston, West Lothian, EH16 4TJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Bipolar DisorderSchizophreniaPersonality DisordersPsychological Well-BeingDepressionPsychotic DisordersNeoplasmsRespiration Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic DisordersPersonal SatisfactionBehaviorBehavioral SymptomsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Douglas Steele

    University of Dundee

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2025

First Posted

February 9, 2026

Study Start

April 3, 2024

Primary Completion

May 30, 2026

Study Completion (Estimated)

August 8, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Anonymous data only - diagnosis (ICD-11 codes), severity ratings (BPRS, IDS-SR, YMRS, Hamilton scales), MHA detention status, treatment resistance indicators (e.g., clozapine, ECT treatment, MGH-S), comorbid physical diagnoses, abnormal findings on physical examination, abnormal laboratory values, cardiometabolic measures

Access Criteria
Anonymous data available to co-investigators - diagnosis (ICD-11 codes), severity ratings (BPRS, IDS-SR, YMRS, Hamilton scales), MHA detention status, treatment resistance indicators (e.g., clozapine, ECT treatment, MGH-S), comorbid physical diagnoses, abnormal findings on physical examination, abnormal laboratory values, cardiometabolic measures

Locations