American skullcap (Scutellaria lateriflora): a study of its effects on mood in healthy volunteers

Completed

• Conditions: Moderate anxiety; Mental and Behavioural Disorders; Other anxiety disorders

• Registration Number: ISRCTN48078312
• Lead Sponsor: niversity of Westminster (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Current inclusion criteria as of 24/03/2011:
1. Aged 18 - 75 years, either sex
2. Good general health
3. Males and females
4. Participants will be volunteers and will have given informed consent
5. Agree to undergo a fingerprick blood test for analysis of liver function pre-, intermediate- and post-intervention

Previous inclusion criteria:
1. Symptoms of moderate anxiety, indicated by a cut-off score point for anxiety on the Beck Anxiety Inventory (BAI) between 16 - 25
2. Aged 18 - 75 years, either sex
3. Good general health
4. Males and females
5. Participants will be volunteers and will have given informed consent
6. Agree to undergo a fingerprick blood test for analysis of liver function pre-, intermediate- and post-intervention

Exclusion Criteria

Current exclusion criteria as of 24/03/2011:
1. Alcohol, tobacco or recreational drug dependence
2. Known hypersensitivity to any herbal medicines when taken orally
3. Current use or use within the past month of antipsychotic medication, e.g., tranquilisers, antidepressants, or sedatives
4. A history of (diagnosed) severe psychiatric disorders, e.g., clinical depression, bipolar disorder or generalised anxiety disorder
5. Neurological, immunological or endocrinological disorders
6. Liver disease, kidney disease, cancer, diabetes mellitus, malignant hypertension or any other serious medical condition
7. Moderate-high depression, i.e., Hospital Anxiety and Depression Scale (HADS) scores 8 - 21
8. Those currently on, or with a recent history of using, synthetic hormones (other than the contraceptive pill), including sprays or topical corticosteroid analogues
9. Those taking herbs or supplements that many have either a direct or indirect effect on the HPA axis (e.g., dopaminergic, serotonergic, gamma-aminobutyric acid [GABA] -ergic)
10. Pregnancy or lactation
11. Those under 18 or over 75
12. Refusal to undergo blood tests

Previous exclusion criteria:
1. Alcohol, tobacco or recreational drug dependence
2. Known hypersensitivity to any herbal medicines when taken orally
3. Current use or use within the past month of antipsychotic medication, e.g., tranquilisers, antidepressants, or sedatives
4. A history of (diagnosed) severe psychiatric disorders, e.g., clinical depression, bipolar disorder or generalised anxiety disorder
5. Neurological, immunological or endocrinological disorders
6. Liver disease, kidney disease, cancer, diabetes mellitus, malignant hypertension or any other serious medical condition
7. Moderate-high depression, i.e., Hospital Anxiety and Depression Scale (HADS) scores 8 - 21
8. Initial scores of above 26 in the BAI, indicating severe anxiety
9. Initial scores below 16 in the BAI, indicating mild anxiety
10. Those currently on, or with a recent history of using, synthetic hormones (other than the contraceptive pill), including sprays or topical corticosteroid analogues
11. Those taking herbs or supplements that many have either a direct or indirect effect on the HPA axis (e.g., dopaminergic, serotonergic, gamma-aminobutyric acid [GABA] -ergic)
12. Pregnancy or lactation
13. Those under 18 or over 75
14. Refusal to undergo blood tests

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in anxiety following 2 weeks' intervention in comparison to placebo control, indicated by a significantly reduced score on the Beck Anxiety Inventory, projected to be at least 10 points (0 - 7 = no anxiety-minimal anxiety; 8 - 15 = mild anxiety; 16 - 25 = moderate anxiety; 26 - 63 = severe anxiety).

Secondary Outcome Measures

Name	Time	Method
1. Self-reported changes in quality of life<br>2. Changes in salivary cortisol measurements to indicate a reduction in stress levels<br>3. Live blood analysis of liver function by fingerprick blood extraction<br><br>Sampling and testing for secondary outcome measures will be conducted prior to commencement of the interventional stage of the study in order to take baseline measurements for comparison with subsequent measurements, during the last 2 days of the first half of the intervention prior to a 7-day washout period and during the last 2 days of the second half of the intervention study following crossover. Pulse and blood pressure will also be assessed at these time-points as a matter of interest.