Serotonin regulation of the human stress response

ISRCTN	ISRCTN77876347
DOI	https://doi.org/10.1186/ISRCTN77876347
Secondary identifying numbers	RA/4/1/1109

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Sean Hood
Scientific

School of Psychiatry and Clinical Neurosciences (M521)
Queen Elizabeth II Medical Centre
Nedlands
Perth
6009
Australia

Phone	+61 (0)8 93462393
Email	sean@cyllene.uwa.edu.au

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	1. Tryptophan depletion will increase the anxiogenic response to single breath 35% CO2 in normal volunteers, as compared with an air inhalation. 2. Single breath 35% CO2 inhalation in normal volunteers will induce cortisol and prolactin release. 3. Tryptophan depletion will significantly increase the magnitude of single breath 35% CO2 induced cortisol and prolactin release in normal volunteers. 4. Tryptophan depletion will exacerbate single breath 35% CO2 inhalation induced hypertension and bradycardia in normal volunteers.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Stress/Anxiety
Intervention	1. Tryptophan depletion, double-blind crossover with Tryptophan restored intervention 2. Single breath 35% CO2 inhalation single blind crossover with single breath room air
Intervention type	Other
Primary outcome measure	Visual Analogue rating Scales (VAS), The Spielberger State Anxiety Inventory (STAI), Cortisol & tryptophan levels.
Secondary outcome measures	The Panic Symptom Inventory (PSI), Prolactin levels, Blood pressure/heart rate data, Swedish universities Scales of Personality (SSP)
Overall study start date	01/04/2005
Completion date	31/07/2005

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	14
Key inclusion criteria	1. Healthy volunteers aged 18-65 2. Able & willing to give informed consent prior to participation
Key exclusion criteria	Any psychiatric morbidity by GP report, psychiatric clinical interview, or MINI v5 (Sheehan et al. 1998) semi-structured interview
Date of first enrolment	01/04/2005
Date of final enrolment	31/07/2005

School of Psychiatry and Clinical Neurosciences (M521)

Perth
6009
Australia

University of Western Australia (Australia)
University/education

35 Stirling Highway
Nedlands
Perth
6009
Australia

University/education

University of Western Australia Research Grants Scheme 2004 (Australia) (ref: RA/1/485/)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2006		Yes	No