Serotonin regulation of the human stress response
| ISRCTN | ISRCTN77876347 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77876347 |
| Protocol serial number | RA/4/1/1109 |
| Sponsor | University of Western Australia (Australia) |
| Funder | University of Western Australia Research Grants Scheme 2004 (Australia) (ref: RA/1/485/) |
- Submission date
- 15/04/2005
- Registration date
- 10/05/2005
- Last edited
- 08/09/2011
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sean Hood
Scientific
Scientific
School of Psychiatry and Clinical Neurosciences (M521)
Queen Elizabeth II Medical Centre
Nedlands
Perth
6009
Australia
| Phone | +61 (0)8 93462393 |
|---|---|
| sean@cyllene.uwa.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Visual Analogue rating Scales (VAS), The Spielberger State Anxiety Inventory (STAI), Cortisol & tryptophan levels. |
| Key secondary outcome measure(s) |
The Panic Symptom Inventory (PSI), Prolactin levels, Blood pressure/heart rate data, Swedish universities Scales of Personality (SSP) |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Australia
Study participating centre
School of Psychiatry and Clinical Neurosciences (M521)
Perth
6009
Australia
6009
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2006 | Yes | No |
