Doluxetine add on conventional treatment in in?ammatory bowel disease patients
Not Applicable
- Conditions
- Condition 1: In?ammatory bowel disease. Condition 2: In?ammatory bowel disease.Crohn disease [regional enteritis]Ulcerative colitis
- Registration Number
- IRCT201411127841N8
- Lead Sponsor
- Isfahan University of Medical Sciences, Psychosomatic Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.