Bipolar Affective DisorderNCT07398365
Medical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients
An observational study of Bipolar Affective Disorder and Schizophrenia Disorders, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Affective Disorder, Schizophrenia Disorders, Depression Disorders
- What is being tested?
- Questionnaires, rating scales, & review of notes
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2024to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥18 years) consecutively admitted to NHS GAP inpatient wards in Scotland.
Who may be able to join
- Adults aged between 18 and 65 years admitted to GAP wards during recruitment period
Who cannot join
- Admissions to non-GAP wards (e.g., forensic psychiatry, young people's units, perinatal, old age psychiatry, or general medical wards)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
St John's Hospital
Livingston, West Lothian, EH16 4TJ
David Hayward, 01506523000, d.a.hayward-1@sms.ed.ac.uk
About this study
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.
Read the 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
- Being tested
- Questionnaires, rating scales, & review of notes
- Keywords
- General Adult Psychiatry, mental health, physical health, inpatients, schizophrenia, NHS, Bipolar affective disorder, depression, psychosis, treatment resistance, personality disorder, cardiometabolic disease, cancer, respiratory disease
- Medical subject headings
- Bipolar Disorder, Schizophrenia, Personality Disorders, Psychological Well-Being, Depression, Psychotic Disorders, Neoplasms, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires, rating scales, & review of notesOther
Observational - questionnaires, rating scales, \& review of notes
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Schizophrenia Group | * Schizophrenia - 6A20
* Schizoaffective disorder - 6A21
* Delusional disorder - 6A24
* Other primary psychotic disorders (psychosis NOS) - 6A2Z
* Schizotypal disorder - 6A23 Receives: 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 Receives: 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 Receives: 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) Receives: Other: Questionnaires, rating scales, & review of notes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of comorbid physical illnesses
As per medical note review and physical examination - BMI
Measured: At enrolment
Psychiatric diagnosis
ICD-11 codes
Measured: At enrolment
Severity of psychosis
Brief Psychiatric Rating Scale (BPRS) score; 18 to 126, higher scores indicate more severe symptoms
Measured: At enrolment
Depression of severity
Inventory of Depressive Symptomatology Self Report (IDS-SR); 0 to 84, higher scores indicate more severe symptoms
Measured: At enrolment
Severity of mania
Young Mania Rating Scale score; 0 to 60, higher scores indicate more severe symptoms
Measured: At enrolment
Severity of anxiety
General Anxiety Scale (GAD-7) score; 0 to 21, higher scores indicate more severe symptoms
Measured: 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
Measured: At enrolment
Mental Health Act status
MHA detention status; informal or detained
Measured: 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
Measured: 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..
Measured: 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.
Measured: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - blood pressure mmHg
Measured: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - cardiometabolic disease
Measured: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - neurological disease.
Measured: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - musculoskeletal disease
Measured: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - respiratory disease
Measured: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - renal disease
Measured: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - hepatic disease
Measured: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - haematological disease
Measured: At enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start3 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Affective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dundee, NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Douglas Steele, Study director, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398365
- Sponsor's protocol ID
- 337967
- Status last verified
- Jun 2026
- First submitted
- 24 Sep 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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