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

NCT ID: NCT02862236

Last Updated: 2018-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-21

Study Completion Date

2018-02-02

Brief Summary

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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

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Conditions

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Subclinical Anxious Adults Nootropic Potential of Hypericum and Alprazolam Healthy Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Hypericum perforatum (Remotiv, 250 mg)

Group Type EXPERIMENTAL

Hypericum perforatum extract

Intervention Type DRUG

250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o.

Hypericum perforatum (Remotiv, 500 mg)

Group Type EXPERIMENTAL

Hypericum perforatum extract

Intervention Type DRUG

250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o.

Interventions

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Hypericum perforatum extract

250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beer Yaakov - Ness Ziona Mental Health Center

OTHER_GOV

Sponsor Role collaborator

Prof. Eldad Yechiam

OTHER

Sponsor Role lead

Responsible Party

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Prof. Eldad Yechiam

Associate Professor, Behavioral Science

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mili Bar-Shaked, MD

Role: PRINCIPAL_INVESTIGATOR

Beer Yaakov - Ness Ziona Mental Health Center

Eldad Yechiam, PhD

Role: STUDY_DIRECTOR

Technion, Israel Institute of Technology

Locations

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Technion, Israel Institute of Technology

Haifa, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 30382352 (View on PubMed)

Other Identifiers

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10-2016

Identifier Type: -

Identifier Source: org_study_id

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