Extract of Ginkgo Biloba and Tardive Dyskinesia
Açar sözlər
Mücərrəd
Təsvir
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.
Tarixlər
Son Doğrulandı: | 04/30/2008 |
İlk təqdim: | 05/01/2008 |
Təxmini qeydiyyat təqdim edildi: | 05/04/2008 |
İlk Göndərmə: | 05/05/2008 |
Son Yeniləmə Göndərildi: | 05/04/2008 |
Son Yeniləmə Göndərildi: | 05/05/2008 |
Həqiqi Təhsilin Başlama Tarixi: | 11/30/2006 |
Təxmini İlkin Tamamlanma Tarixi: | 04/30/2007 |
Təxmini İşin Tamamlanma Tarixi: | 07/31/2007 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Drug: A
Drug: B
Faza
Qol Qrupları
Qol | Müdaxilə / müalicə |
---|---|
Experimental: A Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks | Drug: A EGb-761 240mg/d, 1 capsule(80mg) tid,po,12 weeks; Each capsule contains 19.6mg flavonol glycosides and 4.8mg terpene lactones. |
Placebo Comparator: B Matching placebo treatment | Drug: B Wheat flour placebo capsule,1 capsule tid, po,12 weeks |
Uyğunluq Kriteriyaları
Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
Təhsilə Uyğun Cinslər | All |
Sağlam Könüllüləri qəbul edir | Bəli |
Kriteriyalar | 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) |
Nəticə
İlkin nəticə tədbirləri
1. Change in the scores of Abnormal Involuntary Movement Scale (AIMS) [Baseline, 6th and 12th week]
İkincili Nəticə Tədbirləri
1. Change in PANSS [Baseline, 6th and 12th week]
2. Change in Simpson-Angus Rating Scales for EPS [Baseline, 6th and 12th]
3. Change in cognitive function [Baseline and 12th week]
4. Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale [Baseline, 6th and 12th week]