Extract of Ginkgo Biloba and Tardive Dyskinesia (EGBTD)

Beijing HuiLongGuan Hospital

Status and phase: Completed; Phase 3

Conditions: Tardive Dyskinesia; Schizophrenia

Treatments: Drug: Placebo; Drug: Extract of Ginkgo Biloba (EGb-761 capsules)

Study type: Interventional

Funder types: Other

Identifiers

NCT00672373

BJHLG-20061B0501900035

EGB-ZWF-01

Details and patient eligibility

About

The purpose of this study is to determine whether Extract of Ginkgo Biloba is effective in the treatment on Tardive dyskinesia

Full description

Tardive dyskinesia(TD) is a common complication of conventional antipsychotic treatment in subjects with schizophrenia. There is no established treatment for TD patients.This disorder remains a significant clinical problem for both patients and physicians for the foreseeable future.

Enrollment: 157 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 18 to 60yrs
• Meeting Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition(DSM-IV) criteria for schizophrenia or schizo-affective disorder
• Abnormal Involuntary Movement Scale (AIMS) score ≥2.
• Patients from whom informed, written consent is obtained.
• Patients who have been on a fixed dose of antipsychotic medication for at least 4 weeks prior to trial entry.

Exclusion criteria

• Significant neurological disorder other than TD
• Substance abuse
• Significant other medical illness
• Psychiatric disorder not stabilised
• Pregnancy or lactation
• Take antioxidants(such as Vitamin C)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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157 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks

Treatment:

Drug: Extract of Ginkgo Biloba (EGb-761 capsules)

B

Placebo Comparator group

Description:

Matching placebo treatment

Treatment:

Drug: Placebo