Ginkgo Biloba Extract in the Treatment of Schizophrenia

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

Detailed Description
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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: 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. 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.

Official Title
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The Effects of Ginkgo Biloba Extract in the Treatment of Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Ginkgo Biloba Extract
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, Ginkgo biloba extract, cognition