Effect mirtazapine versus placebo on the treatment of irritable bowel syndrome associated with diarrhea

Effect mirtazapine versus placebo on the treatment of irritable bowel syndrome associated with diarrhea: a double-blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N311

Enrollment

Registered

2019-10-21

Start date

2019-11-22

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Irritable bowel syndrome with diarrhea. Irritable bowel syndrome with diarrhea

Interventions

Intervention 1: Intervention group: Routine treatment plus mirtazapine tablets 15 mg every night for one week and then 30 mg every night for 6 weeks. Intervention 2: Control group: Routine treatment p

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age of 18 to 65 years, Irritable bowel syndrome associated with diarrhea

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding, Taking antidepressants and anxiolytic drugs, Taking anti-diarrhea drugs, History of gastrointestinal surgery except for appendectomy, Diabetes or cardiovascular diseases, Liver or kidney failure, Mental or psychiatric illnesses except for depression and anxiety

Design outcomes

Primary

Measure	Time frame
Anxiety and depression disorder. Timepoint: Before the intervention and 7 weeks after that. Method of measurement: Using the Hospital Anxiety and Depression Scale (HADS).;The severity of irritable bowel syndrome. Timepoint: Before the intervention and 7 weeks after that. Method of measurement: using the irritable bowel syndrome severity Scoring Scale (IBS-SSS).;The quality of life. Timepoint: Before the intervention and 7 weeks after that. Method of measurement: Using the 34-question questionnaire of the irritable bowel syndrome quality of Life (IBS-QoL-34).	—

Measure

Time frame

Anxiety and depression disorder. Timepoint: Before the intervention and 7 weeks after that. Method of measurement: Using the Hospital Anxiety and Depression Scale (HADS).;The severity of irritable bowel syndrome. Timepoint: Before the intervention and 7 weeks after that. Method of measurement: using the irritable bowel syndrome severity Scoring Scale (IBS-SSS).;The quality of life. Timepoint: Before the intervention and 7 weeks after that. Method of measurement: Using the 34-question questionnaire of the irritable bowel syndrome quality of Life (IBS-QoL-34).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShiva Saki

Hamedan University of Medical Sciences

shiva.sky94@gmail.com+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 16, 2026