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

NCT02862236 | Completed Phase 4

• 1 other identifier: 10-2016
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• DASS-21

  one-two hours after drug administration

• PANAS

  one-two hours after drug administration

• STAI

  one-two hours after drug administration

Study Arms (2)

Hypericum perforatum (Remotiv, 250 mg)

EXPERIMENTAL

Drug: Hypericum perforatum extract

Hypericum perforatum (Remotiv, 500 mg)

EXPERIMENTAL

Drug: Hypericum perforatum extract

Interventions

Hypericum perforatum extract DRUG

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

Hypericum perforatum (Remotiv, 250 mg); Hypericum perforatum (Remotiv, 500 mg)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy adults 18 to 40 years old.

You may not qualify if:

• \. Demographics: Under 18 years of age or older than 40; pregnant or nursing women; non-fluent Hebrew speakers.
• \. Body weight: less than 50 kg and more than 90 kg (to ensure effective drug dosage).
• \. 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.
• \. Any motor disability hampering a participant's ability to perform the experimental task.
• \. 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.

Sponsors & Collaborators

• Prof. Eldad Yechiam: lead
• Beer Yaakov - Ness Ziona Mental Health Center: collaborator

Study Sites (1)

Technion, Israel Institute of Technology

Haifa, Israel

Location

Related Publications (1)

• 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.

  PMID: 30382352 DERIVED

MeSH Terms

Interventions

Hypericum extract LI 160

Study Officials

• Mili Bar-Shaked, MD

  Beer Yaakov - Ness Ziona Mental Health Center

  PRINCIPAL INVESTIGATOR

• Eldad Yechiam, PhD

  Technion, Israel Institute of Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Behavioral Science

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 10, 2016
• Study Start: February 21, 2017
• Primary Completion: February 2, 2018
• Study Completion: February 2, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Locations

IL (1)