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A randomized, double-blind, placebo-controlled cross-over study of scopolamine intravenous injection on refractory depression

A randomized, double-blind, placebo-controlled cross-over study of scopolamine intravenous injection on refractory depression

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063641
Enrollment
Unknown
Registered
2022-09-13
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

major depressive disorder

Interventions

Group S/P:scopolamine/placebo intravenous injection
Group P/S:placebo/scopolamine intravenous injection

Sponsors

Huzhou Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of ICD-10 for moderate/severe depression; (2) Meet the criteria of refractory depression; (3) HAMD-17 = 17 points, CGI-S = 3 points; (4) Sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Schizoaffective psychosis, dysthymia or bipolar depression; Any other anxiety disorder was the main diagnosis within 1 year; Substance dependent patients; Personality disorder. (2) Allergic to scopolamine or currently using drugs with obvious drug interaction with this product. (3) Patients with serious or unstable heart, liver, kidney, endocrine (abnormal thyroid function), blood, autoimmune diseases and other medical diseases; Patients with epilepsy or other brain organic diseases; Intractable and refractory hypertension, glaucoma, etc; Severe prostatic hypertrophy; (4) Pregnant or lactating women; (5) A history of serious attempted suicide, or currently at high risk of suicide, or HAMD item 3 suicide score = 3; (6) Abuse of alcohol and psychoactive substances.

Design outcomes

Primary

MeasureTime frame
total score reduce of Hamilton Depression Scale-17 items;

Secondary

MeasureTime frame
total score reduce of Montgomery-Asberg Depression Rating Scale;changes of Young manic rating scale;changes of the scale of Clinical Global Impression;changes of the scale of Perceived Deficits Questionnaire – Depression;changes of the scale of Digit Symbol Substitution Test;changes of the scale of trail-making test;

Countries

China

Contacts

Public ContactPing Guo

Huzhou Third People's Hospital

gp12131997@126.com+8613663753579

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026