Evaluation of the efficacy of zinc sulfate and fluoxetine in comparison with fluoxetine with placebo in children and adolescents with obsessive-compulsive disorder
Investigating the effectiveness of the combination of zinc sulfate and fluoxetine compared to fluoxetine with placebo in children and adolescents with obsessive-compulsive disorder
Design
A clinical trial with the control group, double-blind, randomized, phase 3 on 42 patients, by simple random software.
Settings and conduct
Patients are selected from Besat Hospital and Placement of patients in two groups will be done by simple random method and by software. Then the grouping of the patients is given to the referee specialist and based on the given codes, he puts the necessary drugs in sealed envelopes, which will be numbered on the envelopes, and based on the order of the patient's visits, the corresponding envelope will be given to the patient by the relevant pharmacy. The patient and the doctor do not know about the contents of the envelope. Medicines are placed in capsules in the form of crushed tablets, and the shape of the two medicines is the same.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children aged 10-17 with obsessive-compulsive disorder Exclusion criteria: having another psychiatric disorder.
Intervention groups
The intervention group is the group to which we give fluoxetine and sulfate. We give fluoxetine and placebo to the control group.
Evaluation of the efficacy of zinc sulfate and fluoxetine in comparison with fluoxetine with placebo in children and adolescents with obsessive-compulsive disorder
Public title
Evaluation of the efficacy of Zinc sulfate and fluoxetine in obsessive_compulsive
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 10-17 years
Based on the diagnostic criteria of DSM-5, obsessive-compulsive disorder should be diagnosed in children by a specialist in child and adolescent psychiatry.
Exclusion criteria:
Existence of accompanying psychiatric disorder except for anxiety disorders and oppositional defiant disorder-
Mental retardation based on clinical suspicion
History of allergy to zinc sulfate
Wilson's disease according to medical statements and documents
Liver disease based on medical statements and documents
Spending drug treatments in the previous 2 months
Suicidal thoughts
Age
From 10 years old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done by simple random sampling. Placement or allocation of patients in two groups will be done by simple random method and by software. Then the grouping of the patients is given to the referee specialist and based on the given codes, he puts the necessary drugs in sealed envelopes, which will be numbered on the envelopes, and based on the order of the patient's visits, the corresponding envelope will be given to the patient by the relevant pharmacy. The patient and the doctor do not know about the contents of the envelope. Medicines are placed in capsules in the form of crushed tablets, and the shape of the two medicines is the same.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placement or allocation of patients in two groups will be done by simple random method and by software. Then the grouping of the patients is given to the referee specialist and based on the given codes, he puts the necessary drugs in sealed envelopes, which will be numbered on the envelopes, and based on the order of the patient's visits, the corresponding envelope will be given to the patient by the relevant pharmacy. The patient and the doctor do not know about the contents of the envelope. Medicines are placed in capsules in the form of crushed tablets, and the shape of the two medicines is the same.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Qods hospital, Entezam Blvd, sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
1344666177
Approval date
2022-07-26, 1401/05/04
Ethics committee reference number
IR.MUK.REC.1401.181
Health conditions studied
1
Description of health condition studied
Obssesive_compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Obsessive compulsive scor in Fua et al.'s 2010 Obsessive Compulsive Questionnaire, Children's Version, 21 items (OCI-CV)
Timepoint
At the beginning of the study, 4 weeks later, at the end of 8 weeks.
Method of measurement
Fowa et al.'s 2010 Children's Version 21-item Obsession Questionnaire (OCI-CV)
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" for this group, patients fluoxetine capsules manufactured by Obeid company for the first week (daily, 5 mg in the morning), the second week (daily, 10 mg in the morning) and the third week (Ravazneh, 20 mg) and then from The fourth week onwards based on the patient's tolerance (Ravazneh, 30 mg) plus zinc sulfate manufactured by Al-Hawi company for the first week (daily, 6.25 mg), for the second week (12.5 mg daily) and for the third week onwards Based on the patient's tolerance (25 mg daily in the morning) is given for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: For this group, patients were given a placebo in capsules similar to Alhawi zinc sulfate containing starch, plus fluoxetine capsules made by Obeid company for the first week (daily, 5 mg in the morning), the second week (daily, 10 mg in the morning). and the third week (Ravazaneh, 20 mg) and then from the fourth week onward based on the patient's tolerance (Ravazaneh, 30 mg) is given.