Skip to content

The effect of agomelatine augmentation to SSRI on the treatment of depression in patients with multiple sclerosis

The effect of agomelatine augmentation to SSRI on the treatment of depression in patients with multiple sclerosis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241018063408N1
Enrollment
66
Registered
2024-11-16
Start date
2024-12-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Condition 1: Multiple sclerosis. Condition 2: Major depressive disorder. Multiple sclerosis Major depressive disorder, single episode

Interventions

Intervention 1: Intervention group: the intervention group, participants will receive a single daily dose of 25 mg of agomelatine orally, along with 50 mg of sertraline (or 20 mg of citalopram) admini

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of multiple sclerosis is established through consultation with a neurologist based on the McDonald criteria Absence of relapse episodes one month prior to the initiation of the study. Expression of willingness to participate in the study. Diagnosis of major depressive disorder based on the assessment of a psychiatrist. Absence of other diseases such as chronic illnesses, renal disorders, or musculoskeletal conditions. No history of addiction to alcohol, illicit drugs, or psychoactive substances. Absence of pregnancy and lactation. No presence of other major psychiatric disorders aside from major depressive disorder.

Exclusion criteria

Exclusion criteria: Lack of patient cooperation in completing the questionnaire. Noncompliance with the regular administration of medication. Patient withdrawal from continued participation in the study. Patient's pregnancy.

Design outcomes

Primary

MeasureTime frame
The Hamilton Depression Rating Scale (HDRS) score, with a score of less than or equal to 7, is defined as a response to treatment. Timepoint: At the beginning of the study, one month after the initiation of the intervention, and three months after the commencement of the intervention. Method of measurement: HDRS: Hamilton Depression Rating Scale.

Secondary

MeasureTime frame
MSIS: Multiple Sclerosis Impact Scale;. Timepoint: ?? ?????? ??????? ????? ??? ?? ???? ?????? ? ?? ??? ?? ?? ???? ?????? ????? ?? ????. Method of measurement: MSIS: Multiple Sclerosis Impact Scale;.;FSFI: Female Sexual Function Index;. Timepoint: At the beginning of the study, one month after the initiation of the intervention, and three months after the commencement of the intervention. Method of measurement: FSFI: Female Sexual Function Index.;IIEF: International Index of Erectile Function. Timepoint: At the beginning of the study, one month after the initiation of the intervention, and three months after the commencement of the intervention. Method of measurement: IIEF: International Index of Erectile Function.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid eslami

Mashhad University of Medical Sciences

eslamih4011@mums.ac.ir+98 51 3844 5600

Outcome results

None listed

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