Parkinson‘s disease, Depression
Conditions
Interventions
BTX-A:BOTOX Allergan
Placebo:0.9% Sodium Chloride Injection
Sponsors
Shanghai Tongji Hospital, Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion 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
Exclusion criteria: 1) Cognitive impairment or dementia (MMSE 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the 17-Item Hamilton Depression Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| 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); | — |
Countries
China
Contacts
Public ContactLingjing Jin
Shanghai Tongji Hospital, Tongji University
Outcome results
None listed