Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression

NCT04032795 | Unknown

• 1 other identifier: Guangzhou Brain LBP
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

Lycium barbarum, a traditional Chinese herbal medicine, is a commonly used herb in the traditional Chinese pharmacopoeia . Its main active ingredient, lycium barbarum polysaccharide (LBP), is reported to have neuroprotective effects. Animal studies suggested that LBP has neuroprotective effect on optic ganglion cells. In animal models of depression, LBP can improve depressive symptom by improving synaptic plasticity. However, its clinical effect remains to be studied. We will conduct a 6-week double-blind, randomized, placebo-con-trolled trial in people with subthreshold depression.The purpose of this clinical trial is to investigate the efficacy of LBP in people with subthreshold depression.

Conditions

Subthreshold Depression; Depressive Symptoms; Anxious Symptoms

Keywords

Major Depressive Disorder; Lycium barbarum polysaccharide; depressive symptoms; anxious symptoms

Outcome Measures

Primary Outcomes (1)

• Mean changes from baseline in the 21-item Hamilton Depression Rating Scale (24-HAMD)

  The 24-item HAM-D scale is widely used to assess the severity of depression.The scale is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed).

  6 weeks

Secondary Outcomes (4)

• Changes in The Screen for Child Anxiety Related Disorders (SCARED)

  4 and 6 weeks

• Changes in sleep quality

  6 weeks

• Depression severity as measured by BDI2 and Kessler Scale (K10)

  6 weeks

• Mean change from baseline in the Beck Depression Inventory-II (BDI-2)total scores

  6 week

Other Outcomes (1)

• Treatment-emergent symptom side effect (TESS) scale.

  4 and 6 weeks

Study Arms (2)

Lycium barbarum polysaccharide (LBP)

EXPERIMENTAL

Experimental group takes LBP tablet (300mg/day) for 6 weeks

Dietary Supplement: Lycium barbarum polysaccharide

Placebo

PLACEBO COMPARATOR

Placebo control group takes placebo 6 weeks. The placebos are the same with the LBP tablets in appearance and taste.

Dietary Supplement: Placebo

Interventions

Lycium barbarum polysaccharide DIETARY_SUPPLEMENT

Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day)for 6 weeks

Lycium barbarum polysaccharide (LBP)

Placebo DIETARY_SUPPLEMENT

Placebo-controlled group take he placebo capsules that are identical in shape, color, and taste to LBP tablet.

Placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• scores in the Beck Depression Rating Scale (BDI- II)
• There is no contraindication of taking LBP.

You may not qualify if:

• Current treatment for a mental health problem from a mental health professional
• Current and lifetime history of psychiatric disorders (e.g major depressive disorder, as ascertained by CIDI
• Systemic disease requiring regular medication.
• There are suicidal ideation, suicidal attempt, suicide behavior and attempted suicide.
• Dislike of or allergy to goji berry
• Hormone or Endocrine therapeutic drugs are being taken.
• Long-term use of lycium chinensis in recent three months

Sponsors & Collaborators

• Guangzhou Psychiatric Hospital: lead
• Fifth Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

The Affiliated Fifth Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Related Publications (1)

• Li X, Mo X, Liu T, Shao R, Teopiz K, McIntyre RS, So KF, Lin K. Efficacy of Lycium barbarum polysaccharide in adolescents with subthreshold depression: interim analysis of a randomized controlled study. Neural Regen Res. 2022 Jul;17(7):1582-1587. doi: 10.4103/1673-5374.330618.

  PMID: 34916444 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

lycium barbarum polysaccharide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Kwok-Fai So, PhD

  Guangzhou Medical University

  STUDY CHAIR

• Kangguang Lin, MD,PhD

  Guangzhou Brain Hospital (Guangzhou Huiai Hospital);The fifth affiliated hospital of Guangzhou Medical University

  STUDY DIRECTOR

• Xuan Mo, MD

  Fifth Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

• Guiyun Xu, MD

  Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kangguang Lin, MD

CONTACT

8613560360144; linkangguang@163.com

Xuan Mo, MD

CONTACT

8615622326389; mx7628@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director, Department of Affective disorders

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 25, 2019
• Study Start: May 15, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Locations

CN (1)