Effects of risperidone on glucose metabolism and gut microbiota in healthy adults: an open-label, pilot, randomized controlled trial

JRCT ID: jRCTs041210165

Registered date:22/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 07/07/2022
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Risperidone 0.5 mg, per oral, once per day, before bedtime, for 4 days

Outcome(s)

• Primary Outcome: Change in HOMA-IR from baseline to day 5

Secondary Outcome

1) Changes in the variables from baseline to day 5; blood glucose, insulin, HbA1c, c-peptide, blood pressure, BMI, eGFR, Urinary albumin-creatinine ratio, amino acids, 16S rRNA
2) Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

The study includes those who meet all of the following criteria.
1) Men and women between the ages of 20 and 65
2) No history of psychiatric or neurological disorders
3) Fasting blood glucose level less than 140 mg/dL
4) HOMA-IR (homeostasis model assessment-insulin resistance) 1.6 or higher
5) Estimated GFR 60 ml/min/1.73 m2 or higher
6) AST and ALT less than 30 IU/L
7) No history of arrhythmia or congenital QT prolongation syndrome
8) No history of active cancer (disease-free for 5 years or less)
9) Have a bowel movement at least once every 4 days (regardless of whether or not laxatives are used)
10) The patient's written consent has been obtained after sufficient informed consent for participation in the study

Exclude criteria

Illnesses under treatment
History of hypersensitivity to any of the ingredients of risperidone or paliperidone
Pregnant or lactating mothers
Participation in other clinical studies within 3 months prior to the start of administration of the study drug
Not appropriate as participants
Working at the same or related departments as the principal investigator

Related Information

• Primary Sponsor: Oshima Megumi
• Secondary ID(s): Nil known