Tardive DyskinesiaPhase 3EGBTDNCT00672373

Extract of Ginkgo Biloba and Tardive Dyskinesia

A Phase 3 study testing Extract of Ginkgo Biloba (EGb-761 capsules) in people with Tardive Dyskinesia and Schizophrenia, run by Beijing HuiLongGuan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Tardive Dyskinesia, Schizophrenia
What is being tested?: Extract of Ginkgo Biloba (EGb-761 capsules)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 157 participants
Where: 1 siteChina
Study dates: Dec 2006to Aug 2007
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

China1 site

Beijing Hui-Long-Guan Hospital
Beijing, 100096

Other trials in China

About this study

Official title: A Double-Blind, Randomised, Parallel-Group Comparison of Extract of Ginkgo Biloba(EGB-761) Versus Placebo as Add-on Medication in Patients With Established Tardive Dyskinesia

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

Read the detailed 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.

Conditions: Tardive Dyskinesia, Schizophrenia
Being tested: Extract of Ginkgo Biloba (EGb-761 capsules), Placebo
Keywords: Tardive Dyskinesia, Schizophrenia, Extract of Gingko Biloba
Medical subject headings: Tardive Dyskinesia, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Extract of Ginkgo Biloba (EGb-761 capsules)Drug
Also called YiKangNing
EGb-761 240mg/d, 1 capsule(80mg) tid,po,12 weeks; Each capsule contains 19.6mg flavonol glycosides and 4.8mg terpene lactones.
PlaceboDrug
Wheat flour placebo capsule,1 capsule tid, po,12 weeks

Study groups in NCT00672373
Study group	Role	What they receive
A	Experimental	Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks Receives: Drug: Extract of Ginkgo Biloba (EGb-761 capsules)
B	Placebo comparator	Matching placebo treatment Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the scores of Abnormal Involuntary Movement Scale (AIMS)
Measured: Baseline, 6th and 12th week

Secondary outcomes (4)

Change in PANSS
Measured: Baseline, 6th and 12th week
Change in Simpson-Angus Rating Scales for EPS
Measured: Baseline, 6th and 12th
Change in cognitive function
Measured: Baseline and 12th week
Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale
Measured: Baseline, 6th and 12th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Aug 2007

First posted6 May 2008 (estimated)
Study startDec 2006
Primary completionMay 2007
Study completionAug 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00672373
Sponsor's protocol ID: EGB-ZWF-01
Other IDs: BJHLG-20061B0501900035
Acronym: EGBTD
Status last verified: May 2008
First submitted: 2 May 2008
Last updated: 6 May 2008
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 20868638

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Schizophrenia, Schizoaffective Disorder
Not yet recruitingObservational study
A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms
Extrapyramidal Symptoms, Drug-induced Parkinsonism
RecruitingPhase 4
Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
Tardive Dyskinesia, Intellectual Disability
RecruitingPhase 2
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
Tardive Dyskinesia
Recruiting
Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD
Tardive Dyskinesia, Repetitive Transcranial Magnetic Stimulation

All Tardive Dyskinesia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomised, Parallel-Group Comparison of Extract of Ginkgo Biloba(EGB-761) Versus Placebo as Add-on Medication in Patients With Established Tardive Dyskinesia
ClinicalTrials.gov ID: NCT00672373
Acronym / sponsor ID: EGBTD / EGB-ZWF-01
Conditions: Tardive Dyskinesia, Schizophrenia
Keywords: Tardive Dyskinesia, Schizophrenia, Extract of Gingko Biloba
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 157 participants (actual)
Lead sponsor: Beijing HuiLongGuan HospitalUniversity, hospital or other
Collaborators: Peking University
Study start: Dec 2006
Primary completion: May 2007 (actual)
Study completion: Aug 2007 (actual)
First posted: 6 May 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Extract of Ginkgo Biloba (EGb-761 capsules)Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks
B	Placebo comparator	Drug: PlaceboMatching placebo treatment

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

Significant neurological disorder other than TD
Substance abuse
Significant other medical illness
Psychiatric disorder not stabilised
Pregnancy or lactation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Extract of Ginkgo Biloba (EGb-761 capsules)Also: YiKangNingEGb-761 240mg/d, 1 capsule(80mg) tid,po,12 weeks; Each capsule contains 19.6mg flavonol glycosides and 4.8mg terpene lactones.	Drug	A
PlaceboWheat flour placebo capsule,1 capsule tid, po,12 weeks	Drug	B

Primary outcome

Change in the scores of Abnormal Involuntary Movement Scale (AIMS)
Time frame: Baseline, 6th and 12th week

4 secondary outcomes

Change in PANSS
Time frame: Baseline, 6th and 12th week
Change in Simpson-Angus Rating Scales for EPS
Time frame: Baseline, 6th and 12th
Change in cognitive function
Time frame: Baseline and 12th week
Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale
Time frame: Baseline, 6th and 12th week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2008.
Derived from this study: PubMed 20868638Zhang 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.

Related trials for Tardive Dyskinesia

RecruitingPhase 4
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Schizophrenia, Schizoaffective Disorder
Not yet recruitingObservational study
A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms
Extrapyramidal Symptoms, Drug-induced Parkinsonism
RecruitingPhase 4
Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
Tardive Dyskinesia, Intellectual Disability
RecruitingPhase 2
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
Tardive Dyskinesia
Recruiting
Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD
Tardive Dyskinesia, Repetitive Transcranial Magnetic Stimulation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yunlong Tan, Phd principal investigator

Beijing HuiLongGuan Hospital

Dongfeng Zhou, Professor study chair

Institute of mental health, Peking University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Extract of Ginkgo Biloba (EGb-761 capsules) in people with Tardive Dyskinesia and Schizophrenia, run by Beijing HuiLongGuan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the scores of Abnormal Involuntary Movement Scale (AIMS) (time frame: Baseline, 6th and 12th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00672373, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2008.