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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adults; Subclinical Anxious Adults; Nootropic Potential of Hypericum and Alprazolam
• Intervention / Treatment: Drug: Hypericum perforatum extract

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Technion, Israel Institute of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypericum perforatum (Remotiv, 250 mg)	Drug: Hypericum perforatum extract; 250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o.
Experimental: Hypericum perforatum (Remotiv, 500 mg)	Drug: Hypericum perforatum extract; 250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Digit span task	A computerized cognitive task; accuracy of recalling	one-two hours after drug administration
Symmetry span task	A computerized cognitive task; accuracy of responses	one-two hours after drug administration
Operation span task	A computerized cognitive task; accuracy of responses	one-two hours after drug administration
Groton's Maze task	A computerized task	one-two hours after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DASS-21	A self-report questionnaire; scoring of relevant state anxiety items	one-two hours after drug administration
PANAS	A self-report questionnaire	one-two hours after drug administration
STAI	A self-report questionnaire; scoring of relevant state anxiety items	one-two hours after drug administration

Collaborators and Investigators

• Sponsor: Prof. Eldad Yechiam
• Collaborators: Beer Yaakov - Ness Ziona Mental Health Center
• Investigators: Principal Investigator: Mili Bar-Shaked, MD, Beer Yaakov - Ness Ziona Mental Health Center; Study Director: Eldad Yechiam, PhD, Technion, Israel Institute of Technology

Publications and helpful links

General Publications

• Yechiam E, Ben-Eliezer D, Ashby NJS, Bar-Shaked M. The acute effect of Hypericum perforatum on short-term memory in healthy adults. Psychopharmacology (Berl). 2019 Feb;236(2):613-623. doi: 10.1007/s00213-018-5088-0. Epub 2018 Oct 31.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2017
• Primary Completion (Actual): February 2, 2018
• Study Completion (Actual): February 2, 2018

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 10, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 10-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No