The effect of adding pregabalin to fluoxetine in the treatment of children with anxiety disorders
Phase 3
- Conditions
- Anxiety disorder.Anxiety disorder due to known physiological conditionF06.4
- Registration Number
- IRCT20170108031818N5
- Lead Sponsor
- Gorgan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Age 9-14 years
Children with anxiety disorders based on psychiatrist diagnosis and DSM-5 criteria
New case
Exclusion Criteria
Having accompanying 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
In case of any concomitant medical disorder such as IP, autism, epilepsy
Having physical diseases such as liver disease, heart disease, kidney disease
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anxiety disorder score. Timepoint: Beginning of the study and 8 weeks after the start of the intervention. Method of measurement: Anxiety questionnaire for children and adolescents (YAM-5).;Anxiety severity based on CGAS. Timepoint: Beginning of the study and 8 weeks after the start of the intervention. Method of measurement: Children Global Assessment Scale.
- Secondary Outcome Measures
Name Time Method