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Comparison of the effect of psychiatric drugs on the improvement of psychological symptoms and disease severity in patients with functional dyspepsia

Comparison of the effect of duloxetine with nortriptyline on depression, anxiety, and quality of life in patients with functional dyspepsia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220329054367N2
Enrollment
46
Registered
2022-11-06
Start date
2022-09-23
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

functional dyspepsia. Functional dyspepsia

Interventions

Intervention 1: Intervention group: In the first intervention group, 20 mg duloxetine (Cymbalta brand name) is prescribed for patients. Patients are advised to take the medicine with food. Patients sh

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: All patients with functional dyspepsia based on ROME-IV Having a diploma education Willingness to cooperate in the project Not having an allergy to Deloxetine and Nortriptyline

Exclusion criteria

Exclusion criteria: Having any type of serious psychiatric illness (severe anxiety or depression, psychosis, bipolar disorder, anorexia or bulimia nervosa) Having any other gastrointestinal disease except functional dyspepsia Taking antidepressants or antipsychotics in the last 6 weeks Failure to complete the questionnaires Non-cooperation in follow-ups causing severe side effects of the drug used (Deloxetine or Nortriptyline) Pregnancy or breastfeeding during the study period

Design outcomes

Primary

MeasureTime frame
Anxiety. Timepoint: Measuring anxiety before the start of the study and one, two and three months after the start of the intervention. Method of measurement: Hamilton anxiety questionnaire.;Depression. Timepoint: Measuring depression before the start of the study and one, two and three months after the start of the intervention. Method of measurement: Hamilton depression questionnaire.;Quality of life. Timepoint: Measuring quality of life before the start of the study and one, two and three months after the start of the intervention. Method of measurement: Nippen questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahsa Mofateolshia

Shahid Beheshti University of Medical Sciences

mahsa.3652@gmail.com+98 21 2243 2541

Outcome results

None listed

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