Ginkgo Biloba Extract in the Treatment of Schizophrenia
Study Details
Study Description
Brief Summary
We investigated the effects of Ginkgo biloba extract on the symptoms and cognitive functioning in patients with schizophrenia
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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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.
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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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- clinical symptoms [12 weeks]
symptoms assessed on PANSS
- cognitive functioning [12 weeks]
cognitive functioning assessed on RBANS
Secondary Outcome Measures
- Side effects [12 weeks]
side effect assessed on UKU
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of schizophrenia by two senior psychiatrists
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Between 18 and 60 years and Han Chinese
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Duration of symptoms at least 12 months
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Current psychotic symptoms of moderate severity
Exclusion Criteria:
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A Diagnostic and Statistical Manual of Mental Disorders IV Axis I diagnosis other than schizophrenia
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Documented disease of physical diseases including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure, epilepsy, history of brain trauma；
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Pregnant or breast-feeding female'
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Subjects who suffered from alcohol or illegal durg abuse/dependence
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing HuiLongGuan Hospital | Beijing | China | 100096 |
Sponsors and Collaborators
- Beijing HuiLongGuan Hospital
Investigators
- Principal Investigator: Xiang Y Zhang, M.D, Ph.D, Institute of Psychology, Chinese Academy of Sciences
Study Documents (Full-Text)
None provided.More Information
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. Review.
- 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.
- 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.
- CASPsy4