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

Phase 4

Completed

• Conditions: Subclinical Anxious Adults; Nootropic Potential of Hypericum and Alprazolam; Healthy Adults
• Interventions: Drug: Hypericum perforatum extract

• Registration Number: NCT02862236
• Lead Sponsor: Prof. Eldad Yechiam

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-10
• Study Start: 2017-02-21
• Primary Completion: 2018-02-02
• Study Completion: 2018-02-02
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hypericum perforatum (Remotiv, 250 mg)	Hypericum perforatum extract	-
Hypericum perforatum (Remotiv, 500 mg)	Hypericum perforatum extract	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
DASS-21	one-two hours after drug administration	A self-report questionnaire; scoring of relevant state anxiety items
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

Trial Locations

Locations (1)

Technion, Israel Institute of Technology; 🇮🇱 Haifa, Israel