Early life stress Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 25/07/2023: 1. Aged 18 to 45 years old 2. Physically healthy Previous participant inclusion criteria: 1. Aged 18 years old and over 2. Physically healthy
Exclusion criteria
Exclusion criteria: 1. Current DSM-5 psychiatric disorders measured using the Mini-International Neuropsychiatric Interview (M.I.N.I.) at the first experimental session 5. New psychotropic medication or in receipt of any other type of pharmacological or psychological treatment 6. Pregnancy or/and breastfeeding 7. Hormonal medications 8. Any type of allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Screen participants for eligibility: 1. Current mental disorders are measured using a Mini-International Neuropsychiatric Interview (M.I.N.I.) for DSM-5 at baseline 2. Cognitive impairment is measured using the Cognitive Impairment in Psychiatry (SCIP) test at baseline 3. Posttraumatic stress disorder (PTSD) is measured using the PTSD Checklist for DSM-5 at baseline 4. Early life stress is measured using Childhood Trauma Questionnaire at baseline After screening participants' eligibility to enter the trial, they will be assigned to the ‘Early life stress’ and ‘without Early life stress’ groups and undergo further assessments before and after placebo or hydrocortisone administration (at baseline and on day 4): 1. Levels of anxiety measured using Maudsley Visual Analogue Scales 2. Levels of depression measured using the Patient Health Questionnaire and the Quick Inventory of Depressive Symptomatology 3. Spatial Working Memory measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB) 4. The neuropsychological assessments are measured using Cognitive Remediation in Bipolar (CRiB) Battery 5. Salivary levels of HPA axis activity biomarker cortisol measured using ELISA immediately upon awakening, half an hour later, and one hour afterwards | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom