Healthy Adults, Nootropic Potential of Hypericum and Alprazolam, Subclinical Anxious Adults
Conditions
Brief summary
Rationale Over-the-counter drugs containing hypericum perforatum (H. perforatum), have been argued to improve memory and sustained attention. So far, these claims have not been supported in human studies. However, previous studies used rather high dosages, and little is known about the acute effect of small dosages. Objective We evaluated whether an acute treatment with Remotiv 500 and Remotiv 250 (500 or 250 mg of H. perforatum quantified to either 1 or 0.5 mg of hypericin) improved memory, sustained attention, as well as mood and state anxiety in healthy adults. Method A single dosage, randomized, double blind, placebo-controlled trial was conducted with 82 student participants (33 women). Each participant received placebo in one session and one of two dosages in the other session. Order of the sessions and dosage conditions were randomized between subjects. Participants completed a battery of tasks assessing short-term memory capacity and sustained attention.
Interventions
DRUGHypericum perforatum extract
250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o.
Sponsors
Beer Yaakov - Ness Ziona Mental Health Center
Prof. Eldad Yechiam
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy adults 18 to 40 years old.
Exclusion criteria
* 1\. Demographics: Under 18 years of age or older than 40; pregnant or nursing women; non-fluent Hebrew speakers. 2\. Body weight: less than 50 kg and more than 90 kg (to ensure effective drug dosage). 3\. Mental health: Diagnosed with any DSM-V disorder (including ADHD, learning disabilities). These DSM-V disorders may be included in the research: sexual dysfunctions, sleeping disorders and mild-moderate anxiety disorders. 4\. Any motor disability hampering a participant's ability to perform the experimental task. 5\. Consumption of any psychoactive substance within the last 72 hours. 6. Ongoing medical problems or use of any substances (e.g., other prescribed medications) which may interact negatively with any of the three drugs used in the experiment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Groton's Maze task | one-two hours after drug administration | A computerized task |
| Digit span task | one-two hours after drug administration | A computerized cognitive task; accuracy of recalling |
| Symmetry span task | one-two hours after drug administration | A computerized cognitive task; accuracy of responses |
| Operation span task | one-two hours after drug administration | A computerized cognitive task; accuracy of responses |
| Go/no-go task | one-two hours after drug administration | A computerized cognitive task: aimed to measure attention and impulsivity: errors of omission and commission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PANAS | one-two hours after drug administration | A self-report questionnaire |
| STAI | one-two hours after drug administration | A self-report questionnaire; scoring of relevant state anxiety items |
| DASS-21 | one-two hours after drug administration | A self-report questionnaire; scoring of relevant state anxiety items |
Countries
Israel
Outcome results
None listed