The Acute Effect of Hypericum Perforatum on Short-Term Memory in Healthy Adults

Healthy Adults Clinical Trial

Official title:

The Acute Effect of Hypericum Perforatum on Short-Term Memory in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862236
• Other study ID #: 10-2016
• Status: Completed
• Phase: Phase 4
• Start date: February 21, 2017
• Est. completion date: February 2, 2018

Study information

• Verified date: September 2018
• Source: Technion, Israel Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 2, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adults
• Nootropic Potential of Hypericum and Alprazolam
• Subclinical Anxious Adults

Intervention

Drug:
• Hypericum perforatum extract
250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o.

Locations

Country	Name	City	State
Israel	Technion, Israel Institute of Technology	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Eldad Yechiam	Beer Yaakov – Ness Ziona Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Go/no-go task	A computerized cognitive task: aimed to measure attention and impulsivity: errors of omission and commission	one-two hours after drug administration
Primary	Digit span task	A computerized cognitive task; accuracy of recalling	one-two hours after drug administration
Primary	Symmetry span task	A computerized cognitive task; accuracy of responses	one-two hours after drug administration
Primary	Operation span task	A computerized cognitive task; accuracy of responses	one-two hours after drug administration
Primary	Groton's Maze task	A computerized task	one-two hours after drug administration
Secondary	DASS-21	A self-report questionnaire; scoring of relevant state anxiety items	one-two hours after drug administration
Secondary	PANAS	A self-report questionnaire	one-two hours after drug administration
Secondary	STAI	A self-report questionnaire; scoring of relevant state anxiety items	one-two hours after drug administration