Ginkgo Biloba Extract in the Treatment of Schizophrenia

NCT05258123 | Completed DMC

• 1 other identifier: CASPsy4
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

We investigated the effects of Ginkgo biloba extract on the symptoms and cognitive functioning in patients with schizophrenia

Conditions

Schizophrenia

Keywords

schizophrenia; Ginkgo biloba extract; cognition

Outcome Measures

Primary Outcomes (2)

• clinical symptoms

  symptoms assessed on PANSS

  12 weeks

• cognitive functioning

  cognitive functioning assessed on RBANS

  12 weeks

Secondary Outcomes (1)

• Side effects

  12 weeks

Study Arms (2)

active drug

ACTIVE COMPARATOR

A fixed titration to 360mg （or nine tables） daily of Ginkgo biloba extract was administered with three times daily dosage throughout the study

Drug: Ginkgo Biloba Extract

placebo

PLACEBO COMPARATOR

A nine tables of placebo were administered with three times daily dosage throughout the study

Drug: Placebo oral tablet

Interventions

Ginkgo Biloba Extract DRUG

Ginkgo biloba extract with 360mg was administered

active drug

Placebo oral tablet DRUG

Placebo with nine tables was administered

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of schizophrenia by two senior psychiatrists
• Between 18 and 60 years and Han Chinese
• Duration of symptoms at least 12 months
• Current psychotic symptoms of moderate severity

You may not qualify if:

• A Diagnostic and Statistical Manual of Mental Disorders IV Axis I diagnosis other than schizophrenia
• Documented disease of physical diseases including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure, epilepsy, history of brain trauma；
• Pregnant or breast-feeding female'
• Subjects who suffered from alcohol or illegal durg abuse/dependence

Sponsors & Collaborators

• Beijing HuiLongGuan Hospital: lead

Study Sites (1)

Beijing HuiLongGuan Hospital

Beijing, 100096, China

Location

Related Publications (3)

• Montes P, Ruiz-Sanchez E, Rojas C, Rojas P. Ginkgo biloba Extract 761: A Review of Basic Studies and Potential Clinical Use in Psychiatric Disorders. CNS Neurol Disord Drug Targets. 2015;14(1):132-49. doi: 10.2174/1871527314666150202151440.

  PMID: 25642989 BACKGROUND

• Zheng W, Xiang YQ, Ng CH, Ungvari GS, Chiu HF, Xiang YT. Extract of Ginkgo biloba for Tardive Dyskinesia: Meta-analysis of Randomized Controlled Trials. Pharmacopsychiatry. 2016 May;49(3):107-11. doi: 10.1055/s-0042-102884. Epub 2016 Mar 15.

  PMID: 26979525 BACKGROUND

• Zhang WF, Tan YL, Zhang XY, Chan RC, Wu HR, Zhou DF. Extract of Ginkgo biloba treatment for tardive dyskinesia in schizophrenia: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 May;72(5):615-21. doi: 10.4088/JCP.09m05125yel. Epub 2010 Sep 21.

  PMID: 20868638 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Ginkgo biloba extract

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Xiang Y Zhang, M.D, Ph.D

  Institute of Psychology, Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: February 28, 2022
• Study Start: May 15, 2017
• Primary Completion: June 12, 2018
• Study Completion: August 15, 2018
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)