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

Phase 3
Conditions
Schizophrenia.
Schizophrenia
Registration Number
IRCT201701136691N3
Lead Sponsor
Mazandaran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
40
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

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.
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