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IRCT20211110053031N1 IRCT 2022-06-14 Shiraz University of Medical Sciences Evaluation and comparison of efficacy of atropine eye drops and ipratropium bromide oral spray and amitriptyline tablet in the management of clozapine-induced sialorrhea CIH Evaluation and comparison of efficacy of atropine eye drops and ipratropium bromide oral spray and amitriptyline tablet in the management of clozapine-induced sialorrhea in patients with refractory schizophrenia using the TNHS(Toronto Nocturnal in the management of clozapine-induced sialorrhea in patients with refractory schizophrenia using the TNHS(Toronto Nocturnal Hypersalivation) scale Hypersalivation) scale 2022-07-24 anticipated 1 Complete https://irct.ir/trial/63478 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For random allocation, the quadruple random permutation block method is used. A represents the person receiving the atropine drop and B represents the person receiving the spray Is ipratropium. The total number of 4 permutation block states is 6 (BABA, ABAB, BAAB, ABBA, BBAA, AABB; you assign 0 to 9 to each of the states (using a random number table). And then we produce 12 blocks of 4 (12 * 4 = 48) until 48 people are randomly assigned to two groups, Blinding description: The study is a blind. In this way, only the treating physician does not know what kind of medicine he prescribes, and thus the medicines are placed in numbered envelopes and given to patients. 2 Clozapine-resistant schizophrenic patients with clozapine-induced sialorrhea. Intervention 1: Intervention group: In this group, patients are supposed to receive amitriptyline tablets from Iran Daroo Company at a dose of 25 mg first, and if the clozapine-induced sialorrhea complication does not improve with this dose of amitriptyline, then the dose of amitriptyline can be increased to 100 mg, Administered overnight before bedtime. Intervention 2: Control group: In this group, patients are supposed to use 1% atropine eye drops sublingually from Sinadaru company as one drop three times a day, and if the patient has sialorrhea over night, he can take an extra drop Dissolved in a glass of water and gargle and spill it out. The maximum dose is two drops three times per day. Intervention 3: Intervention group: In this group, patients are supposed to use 0.03% ipratropium bromide nasal spray as one puff twice a day sublingually. If sialorrhea is not controlled, the maximum dose that can be used is two puffs twice a day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Iman Karimzadeh
Roknabad, Shiraz 5Km, Karafarin St., Faculty of Pharmacy
Shiraz Iran (Islamic Republic of) 7146864685 +98 71 3242 4127 karimzadehiman@yahoo.com Shiraz University of Medical Sciences scientific Iman Karimzadeh
Roknabad, Shiraz 5Km, Karafarin St., Faculty of Pharmacy
Shiraz Iran (Islamic Republic of) 7146864685 +98 71 3242 4127 karimzadehiman@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients aged 18 to 65 years with a diagnosis of schizophrenia according to the DSM-V criteria Patients should be receiving clozapine for at least 30 days Patients should have a minimum score of 2 on the TNHS scale for sialorrhea 18 years 65 years Both Development of allergies or history of allergies to amitriptyline, atropine and ipratropium bromide Has an underlying disease such as Parkinson's or cerebral palsy that causes sialorrhea The patient has problems and comorbidities such as untreated constipation or urinary retention or bladder obstruction Concomitant use of drugs such as tricyclic antidepressants and atropine and ipratropium bromide and other anticholinergic drugs Breastfeeding and pregnancy History of diseases such as myasthenia gravis, seizures, cardiac arrhythmias, glaucoma, pyloric obstruction, prostate hypertrophy, renal failure, severe autonomic dysfunction, mental retardation, and paralytic paralysis F20 Schizophrenia Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: In this group, patients are supposed to receive amitriptyline tablets from Iran Daroo Company at a dose of 25 mg first, and if the clozapine-induced sialorrhea complication does not improve with this dose of amitriptyline, then the dose of amitriptyline can be increased to 100 mg, Administered overnight before bedtime. Control group: In this group, patients are supposed to use 1% atropine eye drops sublingually from Sinadaru company as one drop three times a day, and if the patient has sialorrhea over night, he can take an extra drop Dissolved in a glass of water and gargle and spill it out. The maximum dose is two drops three times per day. Intervention group: In this group, patients are supposed to use 0.03% ipratropium bromide nasal spray as one puff twice a day sublingually. If sialorrhea is not controlled, the maximum dose that can be used is two puffs twice a day. Effectiveness score of amitriptyline in reducing clozapine-induced sialorrhea according to TNHS (Toronto Nocturnal Hypersalivation scale). Timepoint: At the beginning of the study, then daily for 7 days, then on days 14, 21 and 28. Method of measurement: Toronto Nocturnal Hypersalivation scale. The effectiveness of atropine eye drops in reducing clozapine-induced sialorrhea according to the TNHS Toronto Nocturnal Hypersalivation Scale. Timepoint: At the beginning of the study, then daily for 7 days, then on days 14, 21 and 28. Method of measurement: Toronto Nocturnal Hypersalivation scale. Effective score of ipratropium bromide nasal spray in reducing clozapine-induced sialorrhea according to TNHS (Toronto Nocturnal Hypersalivation scale). Timepoint: At the beginning of the study, then daily for 7 days, then on days 14, 21 and 28. Method of measurement: TNHS (Toronto Nocturnal Hypersalivation scale). Shiraz University of Medical Sciences Approved 2021-11-16 Ethics committee of Shiraz University of Medical Sciences Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)