An observational study in Bipolar Affective Disorder, Schizophrenia Disorders and Depression Disorders, sponsored by University of Edinburgh. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by University of Edinburgh · Observational
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.
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.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 100 is below the median of 159 across 348 observational studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults (≥18 years) consecutively admitted to NHS GAP inpatient wards in Scotland.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 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)
* 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
* 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
* 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
* 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
Observational - questionnaires, rating scales, \& review of notes
Rates of comorbid physical illnesses
As per medical note review and physical examination - BMI
Time frame: At enrolment
Psychiatric diagnosis
ICD-11 codes
Time frame: At enrolment
Severity of psychosis
Brief Psychiatric Rating Scale (BPRS) score; 18 to 126, higher scores indicate more severe symptoms
Time frame: At enrolment
Depression of severity
Inventory of Depressive Symptomatology Self Report (IDS-SR); 0 to 84, higher scores indicate more severe symptoms
Time frame: At enrolment
Severity of mania
Young Mania Rating Scale score; 0 to 60, higher scores indicate more severe symptoms
Time frame: At enrolment
Severity of anxiety
General Anxiety Scale (GAD-7) score; 0 to 21, higher scores indicate more severe symptoms
Time frame: 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
Time frame: At enrolment
Mental Health Act status
MHA detention status; informal or detained
Time frame: 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
Time frame: 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..
Time frame: 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.
Time frame: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - blood pressure mmHg
Time frame: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - cardiometabolic disease
Time frame: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - neurological disease.
Time frame: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - musculoskeletal disease
Time frame: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - respiratory disease
Time frame: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - renal disease
Time frame: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - hepatic disease
Time frame: At enrolment
Rates of comorbid physical illness
As per medical note review and physical examination - haematological disease
Time frame: At enrolment
Plan to share: 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
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
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