Investigating the effect of adding pregabalin to fluoxetine in the Treatment of children aged 9 To 14 years with anxiety disorders referred To a child and adolescent psychiatric clinic

Determining the effect of adding pregabalin to fluoxetine in the treatment of children with anxiety disorders

Two arm parallel group randomized trial with blinded on 60 Anxious 9 to 14-year-old child.

Patients will be randomly assigned to two intervention groups (fluoxetine and pregabalin treatment recipients) and control group (fluoxetine and placebo treatment recipients). The intervention group will receive daily pregabalin at a dose of 2.5 mg/kg for 8 weeks in addition to their main treatment (fluoxetine syrup in the first week with a dose of 2.5 cc daily and a dose of 5 cc daily from the second week) for 2 months. The control group will also receive a placebo medicine, which looks and tastes the same as pregabalin capsules, in addition to their main treatment (fluoxetine syrup with the same dose and duration). Patients in both groups will be evaluated by questionnaires at the beginning and at the end of the study (end of week 8).

Inclusion criteria age 9–14 years Children with anxiety disorders based on psychiatrist diagnosis and DSM-5 criteria All samples are new Exclusion criteria: having co-occurring mood disorder Psychotic disorder Pervasive developmental disorder Receive any type of psychotherapy Taking psychiatric medications other than SSRIs History of complications and drug sensitivity History of seizures Lack of consent of the patient or legal guardian during the plan Mental and physical retardation If you have any concomitant medical disorder (such as autism and epilepsy) Suffering from physical diseases such as liver diseases, heart diseases, kidney disease

Intervention group (Fluoxetine and Pregabalin treatment recipients) and control group (Fluoxetine and placebo treatment recipients)

Anxiety intensity Anxiety disorder score

In this study, after informed consent was obtained from the parents of eligible children, the participants were divided into two groups A (receivers of fluoxetine and pregabalin main treatment) and B (fluoxetine and placebo) by random block method. They will be. In this way, first, the size of the blocks is considered to be four. Therefore, according to the treatment groups, 6 different combinations are created. Therefore, in the form of randomly placed sampling, 15 blocks are selected based on the table of random numbers obtained by the computer program, and based on that, the samples included in the study will be entered into different groups. This will continue until we reach a sufficient number of samples in each group. For example, if block number 1 is selected in the first selection, it means that the first two samples will enter group A, and the third and fourth samples will enter group B, and the block will be selected again for the next 4 samples. B B A A ۱ B A B A ۲ A B B A ۳ A A B B ۴ A B A B ۵ B A A B ۶

The study is double-blind, the patient and the examining psychiatric assistant will not know the type of treatment.