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Mirtazapine as adjuvant therapy for adolescents with major depressive disorder ageing 12 to 18 years under treatment with sertraline

Mirtazapine as adjuvant therapy for adolescents with major depressive disorder ageing 12 to 18 years under treatment with sertraline; a double blind clinical trail

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250111064353N1
Enrollment
60
Registered
2025-05-01
Start date
2025-04-08
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Major depressive disorder in adolescents aged 12 to 18 years.

Interventions

Intervention 1: Intervention group: Intervention description: Participants in this group will receive mirtazapine as an adjunctive treatment in addition to the usual treatment with sertraline. Drug na

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: Having DSM5 diagnostic criteria for major depressive disorder Age 12 to 18 years Not taking any medication that affects mental status for at least 2 weeks before the study from Persian

Exclusion criteria

Exclusion criteria: The presence of mental retardation The presence of any psychiatric disorder requiring treatment with psychiatric medications, except for major depressive disorder from Persian History of allergy to drugs used in the study Having a serious medical condition, such as heart disease, neurological disease, or a condition requiring surgery from Persian People who have a systolic blood pressure above 125 mm Hg or a resting pulse of less than 60 or above 115 beats per minute. Use of neuroleptic medication in the past 2 weeks Weight under 35 kg Use of any medication or supplement for treatment from Persian History of allergy to mirtazapine and sertraline

Design outcomes

Primary

MeasureTime frame
Variable measurement method: To measure the severity of depression, a validated and standardized Persian version of the CDI questionnaire will be used. The questionnaire will be completed by the adolescents themselves and supervised by a researcher or trained psychologist. Also, to increase accuracy, at both time points, a clinical interview based on DSM-5 criteria will be conducted by a child and adolescent psychiatrist, but the main outcome variable will be analyzed only based on the CDI score. Timepoint: Depression severity will be measured at two time points: at the beginning of the study (baseline), before the start of drug treatment, and eight weeks after the start of treatment (end of intervention). Method of measurement: To measure the severity of depression, a validated and standardized Persian version of the CDI questionnaire will be used. The questionnaire will be completed by the adolescents themselves under the supervision of a researcher or trained psychologist. Also, to increase accuracy, at both time points, a clinical interview based on DSM-5 criteria will be conducted by a child and adolescent psychiatrist, but the main outcome variable will be analyzed only based on the CDI score.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaezeh khosravinia

Shiraz University of Medical Sciences

fafakhosravinia75@gmail.com+98 71 3647 9531

Outcome results

None listed

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