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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01754493
First received: December 11, 2012
Last updated: August 20, 2014
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Major Depression
Irritable Bowel Syndrome Symptoms
Drug: Duloxetine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Up to week 12 ] [ Designated as safety issue: No ]
  • Gastrointestinal Symptoms Rating Scale (GSRS) [ Time Frame: Up to week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinician-Rated Global Impression Scales [ Time Frame: Measured at weeks 0, 1, 2, 3, 4, 6, 8, and 12 ] [ Designated as safety issue: No ]
  • Visual Analogue Scales (VAS) [ Time Frame: Measured at weeks 0, 1, 2, 3, 4, 6, 8, and 12 ] [ Designated as safety issue: No ]
  • Somatization module of the Patient's Health Questionnaire (PHQ-15) [ Time Frame: Measured at weeks 0, 1, 2, 3, 4, 6, 8, and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with Duloxetine
Patients will receive open treatment with Duloxetine
Drug: 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.

Detailed Description:

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. Upon study completion at 12 weeks, they will receive an additional 3 months of free medication treatment at our clinic.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Patients with current or past history of seizure disorder (except febrile seizure in childhood)
  • Patients who are pregnant, breast-feeding or who do not use adequate contraceptive methods. Adequate methods include birth control pills, condom plus spermicide, an intrauterine device, the Norplant system, or diaphragm.
  • Patients who are receiving effective medication for their depression or their IBS symptoms. Patients on effective medication for either disorder will be excluded.
  • Patients on antidepressants and/or anti-IBS medications at intake must still meet inclusion criteria after receiving 3 months or more of medication that was dosed following FDA guidelines. Doses must have been raised so as to produce either intolerable side effects or treatment response.
  • Patients who require treatment with thioridazine for any reason, at baseline and throughout the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754493

Contacts
Contact: Anxiety Disorders Clinic 646-774-7000
Contact: Donna Vermes, RN 646-774-8040 donna@nyspi.columbia.edu

Locations
United States, New York
New York State Psychiatric Institute, 1051 Riverside Drive Recruiting
New York, New York, United States, 10032
Principal Investigator: Roberto Lewis-Fernandez, M.D.         
Sponsors and Collaborators
New York State Psychiatric Institute
Eli Lilly and Company
Investigators
Principal Investigator: Roberto Lewis-Fernandez, M.D. New York State Psychiatric Institute
  More Information

Additional Information:
No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01754493     History of Changes
Other Study ID Numbers: #6479R, F1J-US-X037
Study First Received: December 11, 2012
Last Updated: August 20, 2014
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Major Depression
Irritable Bowel Syndrome
Somatization
Cymbalta
Duloxetine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Irritable Bowel Syndrome
Syndrome
Behavioral Symptoms
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Mental Disorders
Mood Disorders
Pathologic Processes
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on November 19, 2014