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

NCT01754493 | Completed Phase 4 Results

• 2 other identifiers: #6479RF1J-US-X037
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy of duloxetine in reducing depressive symptoms, abdominal pain, and other symptoms of Irritable Bowel Syndrome (IRS) in a population of outpatients with Major Depressive Disorder MDD and clinical symptoms of IBS.

Conditions

Major Depression; Irritable Bowel Syndrome

Keywords

Major Depression; Irritable Bowel Syndrome; Somatization; Cymbalta; Duloxetine

Outcome Measures

Primary Outcomes (2)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  Clinician-administered 10-item scale measuring depressive symptoms (range 0-60); higher scores indicate greater severity of major depression.

  Weeks 0, 8, 12

• Gastrointestinal Symptoms Rating Scale (GSRS)

  Clinician-administered 15-item scale measuring IBS symptoms (range 15-105); higher score indicates greater IBS severity.

  Weeks 0, 8, 12

Secondary Outcomes (3)

• Clinician-Rated Global Impression Scales (CGI)

  Measured at weeks 0, 8, 12

• Visual Analogue Scales (VAS)

  Measured at weeks 0, 8, 12

• Somatization Module of the Patient's Health Questionnaire (PHQ-15)

  Measured at weeks 0, 8, 12

Study Arms (1)

Treatment with Duloxetine

EXPERIMENTAL

Patients will receive open treatment with Duloxetine

Drug: Duloxetine

Interventions

Duloxetine DRUG

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.

Also known as: Cymbalta

Treatment with Duloxetine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets Diagnostic and Statistical Manual,Fourth Edition (DSM-IV) criteria for major depressive disorder (MDD)
• Meets sufficient Rome III criteria for clinical symptoms of IBS
• Able to give consent
• Fluency in English or Spanish
• Patients ages 50-65 must provide a negative colonoscopy report

You may not qualify if:

• Current suicide risk
• History of psychosis, bipolar disorder, or a current diagnosis of Obsessive-Compulsive Disorder (OCD)
• History of alcohol or other substance abuse or dependence in the six months prior to the study
• History of non-response to an adequate trial of duloxetine
• Require concurrent treatment with other psychotropic medication or other psychiatric treatment, except zolpidem for insomnia
• Receive current treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of visit 1 or potential need to use an MAOI during the study or within 5 days of discontinuation of study drug
• Patients with uncontrolled narrow-angle glaucoma
• Received electroconvulsive therapy (ECT) during the last three months
• Unable to tolerate or unwillingness to accept drug-free period of varying length: 1 week for Pro Re Nata (PRN) benzodiazepines; 2 weeks for antidepressants (other than fluoxetine), buspirone, lithium, anticonvulsants, stimulants, barbiturates, opiates, regular-use benzodiazepines (except clonazepam); 5 weeks for clonazepam and fluoxetine
• Clinically unstable medical disease including: Systemic hypertension of 140/90 mm Hg or more; known hypersensitivity to duloxetine or any of its inactive ingredients; liver function test values three times above the normal level; clinically significant thyroid dysfunction, (except patients who are stable on thyroid replacement therapy for at least three months)
• History of chronic, persisting vomiting; rectal bleeding (melena, hematochezia, Bright Red Blood Per Rectum); severe, continuous abdominal pain; nocturnal awakening with GI symptoms; weight loss not clearly related to decreased appetite of MDD; incapacitating symptoms of IBS; severe Upper GI symptoms (e.g., heartburn) that interrupt daily activities
• Family history of Ulcerative Colitis, Crohn's Disease, Celiac Disease or Colon Cancer
• Clinical findings on Physical Exam or laboratory tests of: Rectal bleeding/obstruction, elevated White Blood Cell (WBC) count, unexplained anemia, abnormal Erythrocyte Sedimentation Rate (ESR), abnormal celiac disease panel
• Evidence of clinically significant renal, pulmonary, cerebral vascular, cardiovascular, endocrine disorders, prostatic hypertrophy, urinary retention, laboratory abnormalities, abnormal electrocardiogram
• Cancer of any type. Patients in remission for 5 years or more may be judged acceptable

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

New York State Psychiatric Institute, 1051 Riverside Drive

New York, New York, 10032, United States

Location

Related Links

• Related info

MeSH Terms

Conditions

Depressive Disorder, Major; Irritable Bowel Syndrome

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Study limitations include the lack of placebo control, modest sample size, single ethnic group, and high attrition rate.

Results Point of Contact

• Title: Roberto Lewis-Fernandez
• Organization: New York State Psychiatric Institute

rlewis@nyspi.columbia.edu

646-774-8102

Study Officials

• Roberto Lewis-Fernandez, M.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 21, 2012
• Study Start: December 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 19, 2021
• Results First Posted: November 25, 2016

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)