A Phase 4 interventional study of Duloxetine in Irritable Bowel Syndrome and Generalized Anxiety Disorder, sponsored by West Penn Allegheny Health System. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-07-09.
Sponsored by West Penn Allegheny Health System · Phase 4, Interventional, and Treatment
The investigators propose to evaluate the effectiveness of duloxetine in treating subjects with both Irritable Bowel Syndrome (IBS) and Generalized Anxiety Disorder (GAD). The investigators hypothesize that duloxetine as a single therapeutic agent will effectively target pain and other core symptoms of IBS as well as GAD in this patient population with both conditions.
Generalized Anxiety Disorder (GAD) is commonly associated with Irritable Bowel Syndrome(IBS). The etiology of IBS remains unknown and it is often refractory to treatment. Duloxetine has demonstrated efficacy in the treatment of GAD as well as other pain disorders including fibromyalgia and diabetic neuropathy.
We plan to study 30 subjects with diagnoses of IBS and GAD between the ages of 18 and 65 years. There will be a single-blind placebo-run-in for the first 2 weeks, followed by open-label duloxetine for 12 weeks flexibly titrated to 120 mg/day. Subjects will be informed that they will receive placebo for 2 weeks during the trial. All study visits will be at Allegheny General Hospital Department of Psychiatry. The study consists of a total of nine office visits.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 17 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →West Penn Allegheny Health System is the lead sponsor of 18 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Two weeks of placebo run in followed by 12 weeks of Duloxetine.
Drug: Duloxetine
All subjects will receive single-blind placebo for the first two weeks, and then duloxetine for the next 12 weeks, followed by an up to 2 week taper off of the duloxetine. After 2 weeks of placebo daily, subjects will receive 30 mg per day of duloxetine for two weeks, then titrated up to 60 mg per day of duloxetine at week 2. A dosage decrease to 30 mg daily is permittable after week 2. This will be a flexible dose study with doses of duloxetine progressively increasing at weeks 4 (90 mg daily) and 6 (120 mg daily) in conjunction with CGI-I scores, to reach 120 mg daily or the maximum tolerated dose, if less than 120 mg daily at Week 12. There will be a post-taper follow up appointment at Week 14. Of Note: Amendment IRB Approved 6/14/11 Study Ending at Week 12 with removal of Week 14 visit as part of study.
Also known as: Cymbalta
Clinical Global Impression Scale
The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale. The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 "very much improved", 4 "no change", and 7 "very much worse."
Time frame: endpoint [12 weeks]
Hamilton Anxiety Rating Scale
The HAM-A is a 14 question scale with five responses. Responses range from 0 "not present" to 4 "very severe." The total score ranges from 0 to 56. Higher values represent a worse outcome.
Time frame: endpoint [12 weeks]
Irritable Bowel Syndrome-Quality of Life Scale
The IBS-QOL consists of 34 items, each with a five-point response scale. Ratings range from 1 "not at all" to 5 "extremely" or "a great deal" Higher responses on the scale indicate worse outcome. A minimal total score would be 34, maximum 170.
Time frame: endpoint [12 weeks]
Irritable Bowel Syndrome Severity Scoring System
This is a 4 item Likert scale with each assessment being 100 mm scored from measuring from 0 to 400. Higher numbers indicate worse outcome.
Time frame: endpoint [12 weeks]
Subjects were referred by a gastroenterologist who had Irritable Bowel Syndrome and anxiety.
| Milestone | Treatment Arm |
|---|---|
| Started | 15 |
| Completed | 14 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | Treatment Arm |
|---|---|
| Started | 14 |
| Completed | 11 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Protocol violation | 1 |
The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale. The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 "very much improved", 4 "no change", and 7 "very much worse."
| scores on a scale | Treatment Arm |
|---|---|
| Clinical Global Impression Scale | 2.64 ± 0.5 |
The HAM-A is a 14 question scale with five responses. Responses range from 0 "not present" to 4 "very severe." The total score ranges from 0 to 56. Higher values represent a worse outcome.
| scores on a scale | Treatment Arm |
|---|---|
| Hamilton Anxiety Rating Scale | 9.75 ± 4.5 |
The IBS-QOL consists of 34 items, each with a five-point response scale. Ratings range from 1 "not at all" to 5 "extremely" or "a great deal" Higher responses on the scale indicate worse outcome. A minimal total score would be 34, maximum 170.
| scores on a scale | Treatment Arm |
|---|---|
| Irritable Bowel Syndrome-Quality of Life Scale | 81.73 ± 19.25 |
This is a 4 item Likert scale with each assessment being 100 mm scored from measuring from 0 to 400. Higher numbers indicate worse outcome.
| scores on a scale | Treatment Arm |
|---|---|
| Irritable Bowel Syndrome Severity Scoring System | 187.09 ± 54.05 |
Collected over within 14 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm | — | 0/15 (0%) | 9/15 (60%) |
| Event | Treatment Arm |
|---|---|
| nauseaGastrointestinal disorders | 5/15 |
| fatigueGeneral disorders | 5/15 |
| constipationGastrointestinal disorders | 3/15 |
| dizzinessNervous system disorders | 3/15 |
| dry mouthGastrointestinal disorders | 1/15 |
| anxietyPsychiatric disorders | 1/15 |
| weight gainEndocrine disorders | 1/15 |
| Age, Continuous(years) | Treatment Arm |
|---|---|
| Mean | 42.54 ± 12.70 |
| Sex: Female, Male(Participants) | Treatment Arm |
|---|---|
| Female | 13 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Treatment Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 15 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
No study locations are listed for this record.
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
West Penn Allegheny Health System