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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170108031818N5
Enrollment
60
Registered
2023-06-13
Start date
2023-09-21
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety disorder. Anxiety disorder due to known physiological condition

Interventions

Intervention 1: Intervention group:For 2 months, 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), the

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
9 Years to 14 Years

Inclusion criteria

Inclusion criteria: Age 9-14 years Children with anxiety disorders based on psychiatrist diagnosis and DSM-5 criteria New case

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactfiroozeh derakhshanpoor

Gorgan University of Medical Sciences

dr.derakhshanpoor@gmail.com0173215846

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026