Ginkgo Biloba Extract in the Treatment of Schizophrenia

Schizophrenia Clinical Trial

Official title:

The Effects of Ginkgo Biloba Extract in the Treatment of Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05258123
• Other study ID #: CASPsy4
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: August 15, 2018

Study information

• Verified date: February 2022
• Source: Beijing HuiLongGuan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 15, 2018
• Est. primary completion date: June 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Ginkgo Biloba Extract
Ginkgo biloba extract with 360mg was administered
• Placebo oral tablet
Placebo with nine tables was administered

Locations

Country	Name	City	State
China	Beijing HuiLongGuan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing HuiLongGuan Hospital

Country where clinical trial is conducted

China, 

References & 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical symptoms	symptoms assessed on PANSS	12 weeks
Primary	cognitive functioning	cognitive functioning assessed on RBANS	12 weeks
Secondary	Side effects	side effect assessed on UKU	12 weeks