Clinical trial NCT05180136: Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Adults
Official title: Efficacy and Tolerability of Rice Bran Extract in Mildly to Moderately Depressed Patients: a Double-blind, Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks.

Detailed description: A previous animal study has indicated that rice bran extract provided inhibition of MAO-B enzyme activity and ROS formation in a corticosterone-induced depression-like animal model. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks; the safety of the compound is also evaluated. The Investigators examine the Korean version of the Hamilton Depression Rating Scale, the Korean Version of the Beck-II Depression Inventory, the Korean version of the Patient Health Questionnaire-9, the Perceived Stress Scale, the Korean version of the Beck Anxiety Inventory and biomarkers at baseline and after 8 weeks of intervention. One hundred adults were administered either 1,000 mg of rice bran extract or a placebo each day for 8 weeks.

Eligibility criteria: Inclusion Criteria:

- the Korean version of the Hamilton Depression Rating Scale score between 7-24

Exclusion Criteria:

* No depressive symptom (K-HRSD ≤ 6) or severely depressed (K-HRSD ≥ 25)
* Those are taking hormone therapy such as estrogen within the past 6 months
* Those are taking the following drugs within the last 1 month or need to take them during the study period (sleep aids, antidepressants, selective estrogen receptor modulators, etc.)
* Those with a history of treatment for depression
* Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
* Uncontrolled diabetes mellitus (\>160 mg/dL of fasting blood sugar)
* Uncontrolled hypertension (\>160/100 mmHg)
* Uncontrolled thyroid diseases.
* Those who are taking drugs, functional foods, herbs, etc. that may affect depression
* Alcohol abuser
* Allergic reaction to this test food
* Those who participated in other drug clinical trials within 1 month from the screening date.
* Severe gastrointestinal symptoms such as heartburn and indigestion
* Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
* Those who are judged to be unsuitable by the PI for other reasons

Primary outcomes:
measure: The Korean version of the Hamilton Depression Rating Scale (K-HDRS)
timeFrame: 8 weeks
Secondary outcomes:
measure: The Korean Version of the Beck-II Depression Inventory (K-BDI II)
timeFrame: 8 weeks
measure: The Korean version of the Patient Health Questionnaire-9 (K-PHQ-9)
timeFrame: 8 weeks
measure: The Korean version of the Beck Anxiety Inventory (K-BAI)
timeFrame: 8 weeks
measure: The Korean of the Perceived Stress Scale(K-PSS)
timeFrame: 8 weeks
measure: serotonin concentration (nM)
timeFrame: 8 weeks
measure: Brain-derived neurotrophic factor concentration (ng/ml)
timeFrame: 8 weeks
measure: salivary cortisol concentration (U/mL)
timeFrame: 8 weeks
measure: dopamine concentration (pg/μL)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeungsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: