Clinical trial NCT05258123: Ginkgo Biloba Extract in the Treatment of Schizophrenia
Official title: The Effects of Ginkgo Biloba Extract in the Treatment of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
Ginkgo biloba extract
cognition
Lead sponsor: Beijing HuiLongGuan Hospital
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: clinical symptoms
timeFrame: 12 weeks
measure: cognitive functioning
timeFrame: 12 weeks
Secondary outcomes:
measure: Side effects
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing HuiLongGuan Hospital
Study officials:
affiliation: Institute of Psychology, Chinese Academy of Sciences
name: Xiang Y Zhang, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.