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ISRCTN
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ISRCTN77876347
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ClinicalTrials.gov identifier
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Public title
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Serotonin regulation of the human stress response
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Scientific title
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Acronym
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N/A
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Serial number at source
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RA/4/1/1109
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Stress/Anxiety
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Participants - inclusion criteria
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1. Healthy volunteers aged 18-65
2. Able & willing to give informed consent prior to participation
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Participants - exclusion criteria
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Any psychiatric morbidity by GP report, psychiatric clinical
interview, or MINI v5 (Sheehan et al. 1998) semi-structured interview
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Anticipated start date
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01/04/2005
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Anticipated end date
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31/07/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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14
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Interventions
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1. Tryptophan depletion, double-blind crossover with Tryptophan restored intervention
2. Single breath 35% CO2 inhalation single blind crossover with single breath room air
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Primary outcome measure(s)
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Visual Analogue rating Scales (VAS), The Spielberger State Anxiety Inventory (STAI), Cortisol & tryptophan levels.
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Secondary outcome measure(s)
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The Panic Symptom Inventory (PSI), Prolactin levels, Blood pressure/heart rate data, Swedish universities Scales of Personality (SSP)
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Sources of funding
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University of Western Australia Research Grants Scheme 2004 (Australia) (ref: RA/1/485/)
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16962720
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Contact name
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Dr
Sean
Hood
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Address
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School of Psychiatry and Clinical Neurosciences (M521)
Queen Elizabeth II Medical Centre
Nedlands
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City/town
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Perth
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Zip/Postcode
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6009
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Country
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Australia
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Tel
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+61 (0)8 93462393
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Fax
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+61 (0)8 93463828
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Email
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sean@cyllene.uwa.edu.au
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Sponsor
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University of Western Australia (Australia)
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Address
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35 Stirling Highway
Nedlands
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City/town
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Perth
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Zip/Postcode
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6009
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Country
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Australia
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Email
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kkirk@admin.uwa.edu.au
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Sponsor website:
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http://www.uwa.edu.au/
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Date applied
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15/04/2005
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Last edited
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08/09/2011
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Date ISRCTN assigned
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10/05/2005
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