Botulinum Toxin Relieves Anxiety, Depression and Sleep Disorderes in Patients With Blepharospasm

Early Phase 1

• Conditions: Blepharospasm
• Interventions: Drug: Botulinum toxin type A

• Registration Number: NCT04939909
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Blepharospasm (BSP) is a chronic, idiopathic, recurrent and progressive disease, which mostly occurs in both eyes. It is mainly manifested as involuntary spasm of muscles around the eyes, leading to uncontrollable narrowing or even closure of blepharospasm. Although there is no pain in BSP patients, it can cause social or psychological dysfunction, make patients feel difficult in driving, reading and working, and seriously affect the social, work and life of patients.

Depression and anxiety are common and harmful mental disorders. At present, less than 40% of patients with depression can get effective treatment. Using simple and effective screening tools can effectively improve the detection rate of depression, so that patients can get timely and effective treatment. It is also an effective measure to prevent suicide.

Botulinum toxin type A (BTX-A) has achieved gratifying results in the treatment of dyskinesia. It has been confirmed that BTX-A has a significant effect on BSP. The effective rate is 70% - 90%. About 50% of the patients can regain normal or near normal visual function. At present, no prospective studies have explored this association between blepharospasm and depression / anxiety, and whether BTX-A can improve this mood disorder. Therefore, our research goal is to further study the relationship between blepharospasm and depression / anxiety, sleep in a prospective way, and to determine whether BTX-A treatment will affect depression / anxiety symptoms, so as to provide more theoretical basis for clinical treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-25
• Status Verified: 2021-07
• Study Start: 2021-07-12
• Primary Completion: 2021-12-24
• Study Completion: 2022-07-15
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with blepharospasm who received botulinum toxin injection therapy
• All patients must have had the symptoms of blepharospasm for over six months

Exclusion Criteria

• Glaucoma
• Age-related macular degeneration
• Visual acuity of 20/200 or worse
• Chronic obstructive pulmonary disease
• Cardio cerebral diseases, psychosis
• Loss of limb
• Connective tissue diseases
• Dialysis dependence
• Anyone who was unable to cooperate with the examinations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients treated with Botulinum toxin type A	Botulinum toxin type A	Patients were treated with Botulinum toxin type A

Primary Outcome Measures

Name	Time	Method
Change from baseline blepharospasm evaluation at 3 months	Through study completion, 3 months.	Patients will evaluated the Jankovic Rating scale (JRS)，the total score of JRS is 8, and a change of 2 points in the JRS is clinically meaningful.

Secondary Outcome Measures

Name	Time	Method
Change from baseline anxiety evaluation at 3 months	Through study completion, 3 months.	Patients will evaluated the Generalized Anxiety Disorder 7-item scale (GAD-7) questionnaires with a total score of 21, cut-points of 5, 10, and 15 represent mild, moderate, and severe levels of anxiety symptoms.
Change from baseline depression evaluation at 3 months	Through study completion, 3 months.	Patients will evaluated the personal Health Questionnaire Depression Scale (PHQ-8) with a total score of 24, cut-points of 5, 10, and 15 represent mild, moderate, and severe levels of depressive symptoms.

Trial Locations

Locations (1)

Juan Ye; 🇨🇳 Hangzhou, Zhejiang, China