Protocol summary

Summary
We assessed the efficacy of drug duloxetine or placebo on anxiety, depression, severity of symptoms and quality of life in patients with inflammatory bowel disease. Inclusion criteria include men and women age 18–65 years old who were diagnosed with inflammatory bowel disease with no flair up through past six months and exclusion criteria include lifetime bipolar, psychotic, or obsessive-compulsive disorder; substance use disorders, major depressive disorder or anxiety disorders in the past 6 months and treatment with any psychotropic medication within seven days of beginning of study. The 40 subjects were selected from patients who referred to gastrointestinal clinic of Alzahra Hospital (Isfahan, Iran) during 2013 to 2014. After screening the subjects were divided into two groups of duloxetine and placebo randomly.The study was performed in 12 weeks. In 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. In placebo group the subjects received placebo in the same form and packages as duloxetine. We assessed anxiety, depression, severity of symptoms and quality of life in subjects before and just after the treatment with Hospital Anxiety and Depression Scale, Lichtiger Colitis Activity Index and World Health Organization Quality of Life Instruments respectedly.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201411127841N8
Registration date: 2014-11-17, 1393/08/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-17, 1393/08/26
Registrant information
Name
Mohammad Reza Sharbafchi
Name of organization / entity
Psychiatric group, Isfahan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2457
Email address
sharbafchi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-03-01, 1391/12/11
Expected recruitment end date
2014-03-01, 1392/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of doluxetine add on conventional treatment in inflammatory bowel disease patients, on depression, anxiety quality of life and severity of symptoms
Public title
Doluxetine add on conventional treatment in inflammatory bowel disease patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-65 years aged; current diagnosis of inflammatory 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 five medication half-lives) of beginning of study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar jerib Street
City
Isfahan
Postal code
Approval date
2013-02-15, 1391/11/27
Ethics committee reference number
6/2133/ج

Health conditions studied

1

Description of health condition studied
Inflammatory bowel disease
ICD-10 code
K50
ICD-10 code description
Crohn disease [regional enteritis]

2

Description of health condition studied
Inflammatory bowel disease
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

Primary outcomes

1

Description
Depression
Timepoint
At screening and and after 12 weeks
Method of measurement
Hospital Anxiety and Depression Scale

2

Description
Anxeity
Timepoint
At screening and and after 12 weeks
Method of measurement
Hospital Anxiety and Depression Scale

3

Description
Severity of symptoms
Timepoint
At screening and and after 12 weeks
Method of measurement
Lichtiger Colitis Activity Index

4

Description
Quality of life
Timepoint
At screening and and after 12 weeks
Method of measurement
World Health Organization Quality of Life Instruments

Secondary outcomes

1

Description
Vomiting
Timepoint
At screening and every 2 weeks up to 12 weeks
Method of measurement
History and Physical examination

2

Description
Drowsiness
Timepoint
At screening and every 2 weeks up to 12 weeks
Method of measurement
History and Physical examination

3

Description
Dyspepsia
Timepoint
At screening and every 2 weeks up to 12 weeks
Method of measurement
History and Physical examination

4

Description
Nausea
Timepoint
At screening and every 2 weeks up to 12 weeks
Method of measurement
History and Physical examination

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

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

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastrointestinal clinic of Alzahra Hospital
Full name of responsible person
Mohammad Reza Sharbafchi
Street address
Sofe Street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Psychosomatic Research Center
Full name of responsible person
Dr Hamid Afshar
Street address
Shariati Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Psychosomatic Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences, Department of Psychiatry
Full name of responsible person
Mohammad Reza Sharbafchi
Position
Psychiatrist
Other areas of specialty/work
Street address
Ostandari street, Noor Hospital
City
Isfahan
Postal code
Phone
+98 31 3222 2427
Fax
Email
sharbafchi@resident.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences, Department of Psychiatry
Full name of responsible person
Hamid Afshar
Position
Associate Professor
Other areas of specialty/work
Street address
Ostandari street, Noor Hospital
City
Isfahan
Postal code
Phone
+98 31 3222 2427
Fax
Email
afshar@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences, Department of Psychiatry
Full name of responsible person
Mohammad Reza Sharbafchi
Position
Psychiatrist
Other areas of specialty/work
Street address
Ostandari street, Noor Hospital
City
Isfahan
Postal code
Phone
+98 31 3222 2427
Fax
Email
sharbafchi@resident.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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