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NCT04939909
Botulinum Toxin Relieves Anxiety, Depression and Sleep Disorderes in Patients With Blepharospasm
EARLY_PHASE1 trial testing Botulinum toxin type A in Blepharospasm in 50 participants. Status unknown.
24 December 2021
Quick facts
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 12 July 2021 |
| Primary completion | 24 December 2021 |
| Estimated completion | 15 July 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Botulinum toxin type A (BOTULINUM TOXIN TYPE A) — full drug profile →
Conditions studied
- Blepharospasm — all drugs for Blepharospasm →
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Who can join
Adults 40 to 70, any sex, with Blepharospasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The Correlation between Blepharospasm and Psychological diseases: The Anxiety, Depression and Sleep disorder Study
Zhang H, Gao Q, Xie J, Ye J. · · 2022 · DOI 10.21203/rs.3.rs-1793335/v1
Verify or expand the search:
- PubMed search for NCT04939909
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04939909 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Second Affiliated Hospital, School of Medicine, Zhejiang University
- Last refreshed: 19 July 2022
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