Doluxetine add on conventional treatment in in?ammatory bowel disease patients

Efficacy of doluxetine add on conventional treatment in in?ammatory bowel disease patients, on depression, anxiety quality of life and severity of symptoms

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201411127841N8

Enrollment

Registered

2014-11-17

Start date

2013-03-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Condition 1: In?ammatory bowel disease. Condition 2: In?ammatory bowel disease. Crohn disease [regional enteritis] Ulcerative colitis

Interventions

Intervention 1: Drug group: Duloxetine started with 30 mg once a day for 1 week, and then 60 mg once a day for the next 11 weeks. Intervention 2: Control group: The subjects received placebo in the sa

Treatment - Drugs

Placebo

Drug group: Duloxetine started with 30 mg once a day for 1 week, and then 60 mg once a day for the next 11 weeks.

Control group: The subjects received placebo in the same form and packages as duloxetine for 12 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 18-65 years aged; current diagnosis of in?ammatory bowel disease; having no flair up of disease through past six months. Exclusion criteria: any serious medical condition that may interfere with safe study participation; current lactation, pregnancy or inadequate contraception; current serious suicidal intention or plan; lifetime bipolar, psychotic, or obsessive-compulsive disorder; substance use disorders, major depressive disorder or anxiety disorders in the past 6 months; treatment with any psychotropic medication within seven days (or ?ve medication half-lives) of beginning of study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Depression. Timepoint: At screening and and after 12 weeks. Method of measurement: Hospital Anxiety and Depression Scale.;Anxeity. Timepoint: At screening and and after 12 weeks. Method of measurement: Hospital Anxiety and Depression Scale.;Severity of symptoms. Timepoint: At screening and and after 12 weeks. Method of measurement: Lichtiger Colitis Activity Index.;Quality of life. Timepoint: At screening and and after 12 weeks. Method of measurement: World Health Organization Quality of Life Instruments.	—

Measure

Time frame

Depression. Timepoint: At screening and and after 12 weeks. Method of measurement: Hospital Anxiety and Depression Scale.;Anxeity. Timepoint: At screening and and after 12 weeks. Method of measurement: Hospital Anxiety and Depression Scale.;Severity of symptoms. Timepoint: At screening and and after 12 weeks. Method of measurement: Lichtiger Colitis Activity Index.;Quality of life. Timepoint: At screening and and after 12 weeks. Method of measurement: World Health Organization Quality of Life Instruments.

—

Secondary

Measure	Time frame
Vomiting. Timepoint: At screening and every 2 weeks up to 12 weeks. Method of measurement: History and Physical examination.;Drowsiness. Timepoint: At screening and every 2 weeks up to 12 weeks. Method of measurement: History and Physical examination.;Dyspepsia. Timepoint: At screening and every 2 weeks up to 12 weeks. Method of measurement: History and Physical examination.;Nausea. Timepoint: At screening and every 2 weeks up to 12 weeks. Method of measurement: History and Physical examination.	—

Measure

Time frame

Vomiting. Timepoint: At screening and every 2 weeks up to 12 weeks. Method of measurement: History and Physical examination.;Drowsiness. Timepoint: At screening and every 2 weeks up to 12 weeks. Method of measurement: History and Physical examination.;Dyspepsia. Timepoint: At screening and every 2 weeks up to 12 weeks. Method of measurement: History and Physical examination.;Nausea. Timepoint: At screening and every 2 weeks up to 12 weeks. Method of measurement: History and Physical examination.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Sharbafchi

Isfahan University of Medical Sciences, Department of Psychiatry

sharbafchi@resident.mui.ac.ir+98 31 3222 2427

Outcome results

None listed

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