Condition category
Mental and Behavioural Disorders
Date applied
15/04/2005
Date assigned
10/05/2005
Last edited
08/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sean Hood

ORCID ID

Contact details

School of Psychiatry and Clinical Neurosciences (M521)
Queen Elizabeth II Medical Centre
Nedlands
Perth
6009
Australia
+61 (0)8 93462393
sean@cyllene.uwa.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RA/4/1/1109

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/2005

Overall trial end date

31/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy volunteers aged 18-65
2. Able & willing to give informed consent prior to participation

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

14

Participant exclusion criteria

Any psychiatric morbidity by GP report, psychiatric clinical
interview, or MINI v5 (Sheehan et al. 1998) semi-structured interview

Recruitment start date

01/04/2005

Recruitment end date

31/07/2005

Locations

Countries of recruitment

Australia

Trial participating centre

School of Psychiatry and Clinical Neurosciences (M521)
Perth
6009
Australia

Sponsor information

Organisation

University of Western Australia (Australia)

Sponsor details

35 Stirling Highway
Nedlands
Perth
6009
Australia
kkirk@admin.uwa.edu.au

Sponsor type

University/education

Website

http://www.uwa.edu.au/

Funders

Funder type

University/education

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16962720

Publication citations

  1. Results

    Hood SD, Hince DA, Robinson H, Cirillo M, Christmas D, Kaye JM, Serotonin regulation of the human stress response., Psychoneuroendocrinology, 2006, 31, 9, 1087-1097, doi: 10.1016/j.psyneuen.2006.07.001.

Additional files

Editorial Notes