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Evaluation study for the effect of dl-methylephedrine and pseudoephedrine.

A randomoized, placebo-controlled, double-blind, comparative study to evaluate the effects of dl-methylephedrine and pseudoephedrine on dopamine transporter and brain function in healthy subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031200205
Enrollment
6
Registered
2020-11-26
Start date
2020-11-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy healthy

Interventions

Take the 3 drugs, respectively, then 60 minutes PET scan using [18F] FE-PE2I and 60 minutes fMRI scan from the time when the maximum blood concentration is reached after taking the drugs. 1. dl-methyl

Sponsors

Tateno Amane
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Subjects who are 20 years old or older and younger than 40 years old when obtaining consents 2) Subjects with no history of psychiatric and/or neurological disorders 3) Subjects with normal BMI (18.5-25) 4) Subjects without the history of smoking 5) Subjects who have the ability to provide informed consent and adhere to the protocol.

Exclusion criteria

Exclusion criteria: 1) Subjects who are contraindicated for dl-methylephedrine or pseudoephedrine. a) taking cathecholamines b) with a history of hypersensitivity to dellegra or compouds similar in chemical structure to pseudoephedrine (ephedrine or methylephedrine) c) with severe hypertension d) with severe coronary aretery disease e) with angle-closure glaucoma f) with urinary retention g) with a hisotry of insomnia, dizziness, weakness, tremor, arrhythmia due to sympathomimetics 2) Subjects who are subject to careful administration of dl-methylephedrine or pseudoephedrine. a) with hyperthyroidism b) with hypertension c) with heart disease d) with diabetes mellitus e) with elevated intraocular pressure f) with prostatic hypertrophy g) with renal dysfunction 3) Subjects who have gastrointenstinal symptoms when taking lactose 4) Subjcts who received drug therapy within 1 week before obtaining consent 5) Subjects who are contraindicated for the use of MRI 6) Subjects who took cafein (by 2 days before the test) or alcohol (by the day before the test). 7) Subjects who has been exposed to radiation by job-related exposuer or therapy in one year exceeding 15mSv. 8) Subjects who have received contrast agents (X-ray, MRI) or radiopharmaceuticals within 2 days of the examination, or plan to do the day after the examination. 9) Athletes at the competition level 10) Subjects who do not agree to notify the results of the examination which requires treatment 11) Subjects who are judged as not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
the change of binding potential of dopamine transporter (in striatum, nucleus accumbens, thalamus, substantia nigra)

Secondary

MeasureTime frame
1. the change of BOLD signal 2. Correct answer rate and reaction time of cognitive tasks during fMRI 3. blood and urine concentration of dl-methylephedrine and pseudoephedrine, urine concentration o cafeine 4. evaluation of higher brain function by neuropsychological test 5. evaluation of subjective mood by psychological test

Contacts

Public ContactAmane Tateno

Department of Neuropsychiatry, Nippon Medical School

amtateno@nms.ac.jp+81-3-3822-2131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026