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The effectiveness of fluoxetine in the treatment of depression

Investigating the effectiveness of fluoxetine in the treatment of major depression compared to placebo in children 4-6 years old

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220706055386N1
Enrollment
40
Registered
2022-08-13
Start date
2022-09-06
Completion date
Unknown
Last updated
2022-08-29

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

Conditions

Major Depression. Mood disorder due to known physiological condition with major depressive-like episode

Interventions

Intervention 1: Intervention group: In this group, the prescribed dose of fluoxetine will be such that the prescribed dose for each of the children is 0.7 mg per kilogram of body weight, and in the th

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 6 Years

Inclusion criteria

Inclusion criteria: Age 4-6 years old The diagnosis of depression based on the DSM-V criteria related to the diagnosis of depression in preschool children for the patient must be confirmed by a psychiatrist (severity of depression will be obtained based on a high score by the subject on the revised parent anxiety-depression scale = a score higher than 25 ). No other psychiatric disorders Parents' consent to children's participation in this study No history of previous use of fluoxetine or other psychiatric drugs Not taking drugs that interfere with fluoxetine Not having separate families (single-parent children, children of divorce, having a stepmother or stepfather, or the death of parents)

Exclusion criteria

Exclusion criteria: Lack of parental consent to continue studying at any time of the study Drug side effects caused by fluoxetine use

Design outcomes

Primary

MeasureTime frame
Major Depression. Timepoint: Measurement of major depression at the beginning of the study (before the start of the intervention) and the fourth week and three months after starting the fluoxetine drug. Method of measurement: The Revised Child Anxiety and Depression Scales–Parent Version (RCADS-P).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdieh Soltanian

Esfahan University of Medical Sciences

m.soltanian1353@gmail.com+98 31 3786 1563

Outcome results

None listed

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