major depressive disorder Depression, insomnia, anxiety
Conditions
Interventions
A total of 29 units of type A botulinum toxin will be injected locally into the area between the eyebrows. For the placebo group, the same amount of saline will be injected locally into the same area.
Sponsors
Otsuka Ikuo
Hishimoto Akitoyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients aged between 20 and 65 years old at the time of obtaining consent (2) No restrictions on sex (3) Patients with major depressive disorder undergoing treatment (4) Patients with moderate or severe major depressive disorder, whose HAMD-17 score are 14 or more at the time of screening who have not had their psychotropic medication adjusted and who still have a HAMD-17 score of 14 or more on the day the study begins (5) Patients who have given their written consent to participate in this clinical study of their own free will.
Exclusion criteria
Exclusion criteria: (1) Patients with a history of hypersensitivity to the components of the research drug. (2) Patients with histories of chronic respiratory disorders, severe muscle weakness or atrophy, generalized neuromuscular junction disorders, or angle-closure glaucoma (3) Pregnant women including those who may be, and lactating women (4) Patients who desire to have babies during the study, as contraception is required for women until they have had two menstrual periods after treatment and for men for three months after treatment (5) Patients who have previously undergone BTX treatment (6) Patients who have changed the dosage or regimen of psychotropic drugs within 28 days of obtaining consent (7) Patients being treated with other botulinum toxin products (8) Other patients who are judged to be unsuitable by the principal researcher or co-researchers of this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We use the HAMD-17 as the primary outcome. We conduct HAMD-17 test at screening, treatment initiation, and 8 weeks after treatment. We conduct a single-blind study, dividing the participants into a case group and a control (saline injection) group. The primary endpoint is the difference in mean HAMD-17 scores at the start of treatment and 8 weeks after the start of treatment, between the case and control groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation items We assess the following as secondary outcomes. Odds ratio for treatment type when categorizing treatment effects by HAMD-17 improvement (top 50% and bottom 50% of improvement) Association between treatment type and HAMD-17 in multiple regression analysis with age and sex as confounding factors Difference in mean or median in improvement (change) of MADRS between case and control groups Safety evaluation items Clinical examinations will be conducted within the standard medical care on the day the trial begins, and 4 and 8 weeks after the administration of the test drug, or when the discontinued. In addition, safety will be confirmed for oculomotor disorders, dysphagia, respiratory disorders, and seizure attacks through interviews on the day the trial begins, 4, 8, and 16 weeks after the administration of the test drug. Blood tests Red blood cell count, white blood cell count, neutrophil count, lymphocyte count, hemoglobin level, hematocrit level, platelet count Biochemical tests AST, ALT, ALP, gamma-GTP, TP, Alb, T-Bil, BUN, Cre, T-Cho, TG, LDH, CK, Na, K, Cl, UA, BS, HDL-C, LDL-C | — |
Contacts
Public ContactKyoko Shimizu
Kobe University Hospital
Outcome results
None listed