Clinical trial NCT02862236: The Acute Effect of Hypericum Perforatum on Short-Term Memory in Healthy Adults
Official title: The Acute Effect of Hypericum Perforatum on Short-Term Memory in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subclinical Anxious Adults
Nootropic Potential of Hypericum and Alprazolam
Healthy Adults
Lead sponsor: Technion, Israel Institute of Technology
Sponsor class: OTHER
Collaborators: name: Beer Yaakov - Ness Ziona Mental Health Center
First posted: 2016-08-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Go/no-go task
timeFrame: one-two hours after drug administration
measure: Digit span task
timeFrame: one-two hours after drug administration
measure: Symmetry span task
timeFrame: one-two hours after drug administration
measure: Operation span task
timeFrame: one-two hours after drug administration
measure: Groton's Maze task
timeFrame: one-two hours after drug administration
Secondary outcomes:
measure: DASS-21
timeFrame: one-two hours after drug administration
measure: PANAS
timeFrame: one-two hours after drug administration
measure: STAI
timeFrame: one-two hours after drug administration
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Technion, Israel Institute of Technology
Study officials:
affiliation: Beer Yaakov - Ness Ziona Mental Health Center
name: Mili Bar-Shaked, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Technion, Israel Institute of Technology
name: Eldad Yechiam, PhD
role: STUDY_DIRECTOR
References:
citation: 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.