Ginkgo Biloba Extract in the Treatment of Schizophrenia

The Effects of Ginkgo Biloba Extract in the Treatment of Schizophrenia

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Ginkgo Biloba Extract; Drug: Placebo oral tablet

Detailed Description

Objective: This study aimed to evaluate the effect of Ginkgo biloba extract in the treatment of symptoms and cognitive functioning in 200? chronic patients with schizophrenia

Methods:

1. Clinical Trial: This is a randomized, double-blind and parallel controlled trial in the chronic patients with schizophrenia. The study consists of 12 weeks of double-blind treatment.
2. Assessment Procedures:

2.1 Primary Outcome Variable: Patients were assessed by two clinical trained staff, who were blind to the treatment protocols, by using the Positive and Negative Syndrome Scale (PANSS) to assess the psychopathology and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) to evaluation the cognitive functioning. Patients were interviewed at screening, and at baseline, 4? weeks, 12? weeks.

2.2 Side effects: The side effect rating scale (UKU) was used to assess the side effect at baseline, 4? weeks, and 12? weeks.

2.3 Weight gain measurement: weigh was measured every week.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100096
    • Beijing Huilongguan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active drug; 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; Ginkgo biloba extract with 360mg was administered
Placebo Comparator: placebo; A nine tables of placebo were administered with three times daily dosage throughout the study	Drug: Placebo oral tablet; Placebo with nine tables was administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical symptoms	symptoms assessed on PANSS	12 weeks
cognitive functioning	cognitive functioning assessed on RBANS	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	side effect assessed on UKU	12 weeks

Collaborators and Investigators

• Sponsor: Beijing HuiLongGuan Hospital
• Investigators: Principal Investigator: Xiang Y Zhang, M.D, Ph.D, Institute of Psychology, Chinese Academy of Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): June 12, 2018
• Study Completion (Actual): August 15, 2018

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: cognition; schizophrenia; Ginkgo biloba extract
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: CASPsy4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data with be available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No