World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 24 July 2017
Main ID:  ChiCTR-INR-17012013
Date of registration: 2017-07-17
Prospective Registration: Yes
Primary sponsor: Shanghai Tongji Hospital, Tongji University
Public title: Clinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's disease
Scientific title: Clinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's disease
Date of first enrolment: 2017-09-01
Target sample size: BTX-A:40;Placebo:40;
Recruitment status: Pending
URL:  http://www.chictr.org.cn/showproj.aspx?proj=20370
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  New Treatment Measure Clinical Study
Countries of recruitment
China
Contacts
Name: Zhuoyu Zhang   
Address:  389 Xincun Road, Shanghai, China
Telephone: +86 15316663713
Email: Dr.zzy@tongji.edu.cn
Affiliation:  Shanghai Tongji Hospital, Tongji University
Name: Lingjing Jin   
Address:  389 Xincun Road, Shanghai, China
Telephone: +86 15021312377
Email: lingjingjin@163.com
Affiliation:  Shanghai Tongji Hospital, Tongji University
Key inclusion & exclusion criteria
Inclusion criteria: 1) Aged 18-80 years old;
2) Diagnosis of Parkinson's disease (There must be bradykinesia and at least one of the following signs: resting tremor, rigidity, or postural reflex impairment. No other problem that is clear or suspected to cause Parkinson's syndromeno other clear or suspected to cause Parkinson's syndrome), Hoehn and Yahr Scale =1 and =3 (treatment); the 17-Item Hamilton Depression Rating Scale (HDRS-17) =14, Unified Parkinson 's disease rating scale Part 1 depression score =2;
3) If the drug is taken, the dopa preparations, amantadine, anticholinergic drugs, catechol-O-methyltransferase inhibitors or monoamine oxidase B inhibitors must be stable for 4 weeks before baseline; Antidepressant, dopamine receptor agonist drugs must be stable in the 8 weeks prior to study entry;
4) Willingness to involve the study and remain unchanged for the original treatment.

Exclusion criteria: 1) Cognitive impairment or dementia (MMSE score <18 points);
2) Suicidal plans or intent (HAMD suicide entry =4 or MINI Suicidality score> 17 points);
3) A clear history of primary depression or other mental illness history (diagnosis of Parkinson's disease 10 years before the diagnosis of depression);
4) Currently accept systemic psychotherapy;
5) Botulinum toxin was used in the 12 months prior to study;
6) Allergy to botulinum toxin or has other botulinum toxin use contraindications;
7) Eyebrow skin infection;
8) Drugs or alcohol abusers, Patients with severe coagulation dysfunction or hemorrhagic disease, severe heart, liver, kidney and other organs dysfunction;
9) Pregnant women and lactating women;
10) Patients with myasthenia gravis or myasthenia gravis.


Age minimum: 18
Age maximum: 80
Gender: Both
Health Condition(s) or Problem(s) studied
Parkinsonā€˜s disease, Depression
Intervention(s)
BTX-A:BOTOX Allergan;Placebo:0.9% Sodium Chloride Injection;
Primary Outcome(s)
the 17-Item Hamilton Depression Rating Scale;
Secondary Outcome(s)
Patient Health Questionnaire (PHQ-9);Clinical Global Impression-Severity (CGI-S);the 12-items Short Form Health Survey (SF-12);the four-point Clinical Severity Score for Glabellar Frown Lines (CSS-GFL);
Secondary ID(s)
Source(s) of Monetary Support
Research project
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history