Comparison of effect of atropine drops and Amitriptyline tablet in clozapine-induced hypersalivation

Comparison of effects of atropine drops and Amitriptyline tablets in clozapine-induced hypersalivation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201701136691N3

Enrollment

Registered

2017-02-15

Start date

2017-01-20

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Schizophrenia. Schizophrenia

Interventions

Intervention 1: Within 4 weeks 1 group of patient will recieve Amytriptiline tablet and Placebo drop . Intervention 2: within 4 weeks other group will recieve Atropine drop and placebo tablet.

Treatment - Drugs

Within 4 weeks 1 group of patient will recieve Amytriptiline tablet and Placebo drop .

within 4 weeks other group will recieve Atropine drop and placebo tablet.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Every hospitalized patient taking Clozapine and recieved diagnosis of Schizophrenia, Schizoaffective or other psychiatric disorders according to DSM-IV ; Age between 18-65 year old ; Having nacturnal sialorrhea more than 2 scores based on TNHS ; Agreement and optional participation of patients is necessary. Exclusion criteria: Sensitivity to Atropine and Amitriptyline ; Comorbidity with other diseases produce sialorrhea like Parkinson dx and Cerebral palsy ;Affliction with untreated constipation, Bladder outlet obsrtuction and urinary retention; Co-consumption of anticholinergic drugs ; Lactation &Pregnancy ; past positive history of myasthenia gravis, Cardiac arrythmia, Glucoma, Pyloric obsrtruction,Paralytic ileus, Prostatic hypertrophia and Renal dysfunction ; Sever dysoutonomy 8. Mental retardation 9. Bipolar schizoaffective and Bipolar mood disorder

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Severity and Frequency of sialorhea. Timepoint: Daily in first week and then weekly until4 weeks. Method of measurement: Toronto Nacturnal Hypersalivation Scale,Drooling scale.	—

Secondary

Measure	Time frame
Palpitation. Timepoint: Baseline and weeks 1-2-3-4 after begining of treatment. Method of measurement: puise rate measuring at Baseline and weeks 1-2-3-4 after begining of treatment.;Hypertension. Timepoint: Baseline and weeks 1-2-3-4 after begining of treatment. Method of measurement: Blood pressure measuring at Baseline and weeks 1-2-3-4 after begining of treatment.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Fatemeh Sheikhmoonesi

Mazandaran University of Medical Sciences

fmoonesi@mazums.ac.ir+98 11 3328 5109

Outcome results

None listed

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