Cortisol reactivity as a biomarker for depression

ISRCTN	ISRCTN84990302
DOI	https://doi.org/10.1186/ISRCTN84990302
Secondary identifying numbers	7554; G0801443

Submission date: 12/05/2010
Registration date: 12/05/2010
Last edited: 13/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Wilkinson
Scientific

Developmental Psychiatry Section
University of Cambridge
Douglas House
18b Trumpington Road
Cambridge
CB2 8AH
United Kingdom

Study information

Study design	Single-centre screening clinical laboratory study
Primary study design	Observational
Secondary study design	Single-centre
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Cortisol hyper-reactivity to stress - a putative biomarker for major depressive disorder
Study objectives	1. Cortisol hyper-reactivity is differentially present in individuals at high risk for depression 2. Cortisol hyper-reactivity is associated with negative cognitive biases proven to be associated with depression 3. Cortisol reactivity to stress is more strongly associated with risk factors for depression than are basal measures of cortisol
Ethics approval(s)	Cambridgeshire 2 REC, 18/06/2009, ref: 09/H0308/69
Health condition(s) or problem(s) studied	Topic: Mental Health Research Network; Subtopic: Depression, Stress-related and somatoform; Disease: Depression, Stress-related and somatoform disorders
Intervention	35% Carbon Dioxide Vital Capacity Inhalation Stress Test: Participants insert the mouthpiece into their mouth. The three-way valve is set so they are breathing air. The experimenter asks the participant to breathe fully out, then take a breath as deep as they can, and hold it for 4 seconds, as a practice. The valve is changed so the CO2 tank is connected to the bag reservoir. The reservoir is filled. The valve is changed so the mouthpiece is attached to the CO2 in the reservoir. The participant breathes in and holds as with the practice. Trier Social Stress Test: The experimenter leads the participant to the experimental room at time 0, where they are introduced to two people (the 'committee'), a microphone and a video-camera. The experimenter tells the participant that they will have to deliver a speech for a job application to the committee, followed by another task, that will be detailed then. They are given instructions by the committee, then prepare their speech until T +3 min. They are asked to deliver the speech. If they stop before 5 minutes, or their speech is not relevant, there are standard questions and prompts. Then they are asked to do the second task, where they must serially subtract 13 from 1022 as quickly and accurately as possible. After mistakes, they are asked return to 1022 and re-start. This lasts 5 minutes, then the task ends. Each test happens once, and follow-up is for 60 minutes after start of test.
Intervention type	Other
Primary outcome measure	Salivary cortisol area under the curve in the time period after intervention, collected 20 minutes before and immediately before, and 20, 30, 40 and 60 minutes after, the onset of each stress test.
Secondary outcome measures	1. Performance on affective go:no go, measured at rest (before first stress test) and 30 minutes after the start of each stress test 2. Ratio of negative to positive words correctly recalled, measured at rest (before first stress test) and 25 minutes after the start of each stress test 3. Which stress test leads to largest rise in cortisol?
Overall study start date	13/04/2010
Completion date	31/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 228
Key inclusion criteria	1. Aged 16 - 21 years old 2. Male and female 3. Recruited from Roots study
Key exclusion criteria	1. Take regular steroid medication (oral or inhaled) or take hormonal contraceptives containing oestrogens (combined pill, injection, implant or patch) 2. Hypertension requiring regular treatment 3. Systolic blood pressure above 140 mmHg or resting pulse over 100 mmHg at the start of the study 4. Current respiratory disease, e.g., asthma 5. A personal or family history (parent or sibling) of panic disorder 6. Significant claustrophobia 7. Smoke daily; no smoking on day of assessment 8. Migraine within the last year 9. Current heart disease 10. Females will be excluded if they are or think they might be pregnant, are lactating, or their menstrual cycle has not returned to being regular after pregnancy 11. At least one biological grandparent known to be non-white European 12. At least one of the following psychiatric disorders at time of interview: anxiety disorder, OCD, oppositional defiant disorder, PTSD, conduct disorder, bipolar disorder 13. Alcohol or illicit drug use on the day of or the day before research assessment 14. Caffeine use since breakfast on the day of research assessment 15. Consume large amounts of caffeinated drinks on a regular basis (greater than six cups of coffee per day or drinks containing methylxanthines such as Pepsi or red bull) 16. Current severe cold or flu 17. Vigorous exercise for 2 hours before testing Additional group-specific criteria: 18. Never-depressed participants: 18.1. No lifetime history of major depressive disorder 18.2. No lifetime history of at least one of the following psychiatric disorders: anxiety disorder, OCD, oppositional defiant disorder, PTSD, conduct disorder, bipolar disorder, ADHD 19. Recovered-depressed: 19.1. At least one past episode of major depressive disorder 19.2. At least 8 weeks of having fewer than two depressive symptoms since last episode 19.3. Not currently taking antidepressants 19.4. No lifetime history of ADHD, autism, conduct disorder with onset before age 11
Date of first enrolment	13/04/2010
Date of final enrolment	31/01/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Developmental Psychiatry Section

Cambridge
CB2 8AH
United Kingdom

Sponsor information

Cambridgeshire and Peterborough NHS Foundation Trust (UK)
Hospital/treatment centre

Cambridge Road
Fulbourn
Cambridge
CB21 5EF
England
United Kingdom

Phone	--
Email	natercia.godinho@cpft.nhs.uk
Website	http://www.cpft.nhs.uk/
"ROR"	https://ror.org/040ch0e11

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: G0801443)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

13/04/2017: No publications found in PubMed, verifying study status with principal investigator.