Effect of Hyoscine (N-Butyl Bromide) on Clozapine-induced Sialorrhea in Schizophrenic Patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191218045795N3

Enrollment

Registered

2020-04-22

Start date

2019-09-23

Completion date

Unknown

Last updated

2020-05-18

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

Conditions

Clozapin induced sialorrhea.

Interventions

Intervention 1: Intervention group: Hyoscin powder, manufactured by tehran chemie Pharmaceuticals and weighed with 10 mg precision scales,5mg is poured into the empty capsules. Patients receive 15mg

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Take Clozapine for at least two weeks or more a score of 4 or more on the DRS grading scale

Exclusion criteria

Exclusion criteria: Having unstable medical conditions such as unstable angina, uncontrolled diabetes or concomitant alcohol use Having any serious illness affecting cognition and the brain including epilepsy, serious head injury, brain tumor, HIV infection and other neurological disorders Pregnancy and planning for pregnancy during the study

Design outcomes

Primary

Measure	Time frame
Comparison of the hyoscin and placebo effect on clozapine induced sialorrhea. Timepoint: Weeks: 1, 2 and 5. Method of measurement: Drooling Rating scale (DRS).;Cognitive function. Timepoint: Weeks: 1, 2 and 5. Method of measurement: Questionnaire for Mini mental state examination (MMSE).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNarges Shams Alizadeh

Sanandaj University of Medical Sciences

n.shamsalizadeh@muk.ac.ir+98 87 3366 0026

Outcome results

None listed

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