Effects of Gastric Bypass on Blood Levels of Duloxetine
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ClinicalTrials.gov Identifier: NCT00989157 |
Recruitment Status
:
Completed
First Posted
: October 2, 2009
Results First Posted
: August 11, 2014
Last Update Posted
: August 11, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bariatric Surgery | Drug: Duloxetine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Active drug
All subjects received drug. Single arm.
|
Drug: Duloxetine
Single dose of 60 mg of duloxetine
Other Name: Cymbalta
|
- Cmax [ Time Frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 ]The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender.
- Tmax [ Time Frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 ]Time to maximum plasma concentration
- AUCo-inf, [ Time Frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 ]Area under the plasma concentration time curve
- T1/2 [ Time Frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 ]Half life
- Emesis [ Time Frame: 4 days ]episodes of emesis.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female subjects between the ages of 18 and 60 years.
- Subjects must be of good general health by history and physical exam.
- Ten experimental subjects 9 to 15 months post bariatric surgery (Roux-en-Y procedure), no BMI requirement.
- Ten normal control subjects who have met the inclusion criteria and have not received bariatric surgery and who are matched to the surgery subjects according to body mass index, age and sex.
- Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline.
- No contraindications to receiving a single capsule of 60 mg of duloxetine
Exclusion Criteria:
- Allergy to duloxetine or any of its constituents.
- Candidates who are pregnant or nursing
- Candidates currently receiving any antidepressant.
- Candidates that are determined to be poor metabolizers for CYP2D6
- Subjects who smoke or use any nicotine products
- Candidates currently receiving a medication that interacts with duloxetine.
- Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease.
- Candidates experiencing or with a history of vomiting or diarrhea associated with bariatric surgery
- Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder.
- Candidates who have participated in an investigational drug study in past 30 days.
- Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or who have a history of drug/alcohol abuse or dependency.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989157
United States, North Dakota | |
Neuropsychiatric Research Institute | |
Fargo, North Dakota, United States, 58103 |
Principal Investigator: | James L Roerig, PharmD, BCPP | Neuropsychiatric Research Institute and University of North Dakota |
Additional Information:
Responsible Party: | James Roerig, James L Roerig, PharmD, BCPP, Neuropsychiatric Research Institute and University of North Dakota, Neuropsychiatric Research Institute, Fargo, North Dakota |
ClinicalTrials.gov Identifier: | NCT00989157 History of Changes |
Other Study ID Numbers: |
F1J-US-X054 |
First Posted: | October 2, 2009 Key Record Dates |
Results First Posted: | August 11, 2014 |
Last Update Posted: | August 11, 2014 |
Last Verified: | July 2014 |
Keywords provided by James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota:
Gastric Bypass Duloxetine Cymbalta Pharmacokinetics |
Additional relevant MeSH terms:
Duloxetine Hydrochloride Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Dopamine Agents |