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Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression (IBS-MDD)

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ClinicalTrials.gov Identifier: NCT01754493
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : November 25, 2016
Last Update Posted : November 25, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Major Depression
Irritable Bowel Syndrome
Intervention: Drug: Duloxetine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study participants were recruited through print and electronic advertisements (n=12). We also received referrals from community clinicians (n=3), a former patient (n=1) and a psychiatric help line (n=1). Recruitment took place from 1/19/07 to 5/20/14.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study was a single-arm open trial, so all the participants were assigned to the open-label duloxetine treatment arm.

Reporting Groups
  Description
Treatment With Duloxetine

Patients will receive open treatment with Duloxetine

Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms.


Participant Flow:   Overall Study
    Treatment With Duloxetine
STARTED   17 
COMPLETED   10 
NOT COMPLETED   7 
Adverse Event                1 
Lost to Follow-up                3 
Withdrawal by Subject                1 
Moved out of town                1 
Scheduling conflict                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment With Duloxetine

Patients will receive open treatment with Duloxetine

Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) symptoms and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms.


Baseline Measures
   Treatment With Duloxetine 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.7  (11.0) 
Gender 
[Units: Participants]
Count of Participants
 
Female      13  76.5% 
Male      4  23.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      17 100.0% 
Not Hispanic or Latino      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   17 


  Outcome Measures

1.  Primary:   Montgomery-Asberg Depression Rating Scale (MADRS)   [ Time Frame: Weeks 0, 8, 12 ]

2.  Primary:   Gastrointestinal Symptoms Rating Scale (GSRS)   [ Time Frame: Weeks 0, 8, 12 ]

3.  Secondary:   Clinician-Rated Global Impression Scales (CGI)   [ Time Frame: Measured at weeks 0, 8, 12 ]

4.  Secondary:   Visual Analogue Scales (VAS)   [ Time Frame: Measured at weeks 0, 8, 12 ]

5.  Secondary:   Somatization Module of the Patient's Health Questionnaire (PHQ-15)   [ Time Frame: Measured at weeks 0, 8, 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study limitations include the lack of placebo control, modest sample size, single ethnic group, and high attrition rate.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Roberto Lewis-Fernandez
Organization: New York State Psychiatric Institute
phone: 646-774-8102
e-mail: rlewis@nyspi.columbia.edu



Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01754493     History of Changes
Other Study ID Numbers: #6479R
F1J-US-X037 ( Other Grant/Funding Number: Eli Lilly and Company )
First Submitted: December 11, 2012
First Posted: December 21, 2012
Results First Submitted: September 6, 2016
Results First Posted: November 25, 2016
Last Update Posted: November 25, 2016