Effects of Gastric Bypass on Blood Levels of Duloxetine

Neuropsychiatric Research Institute, Fargo, North Dakota

Status and phase

Completed

Phase 3

Conditions

Bariatric Surgery

Treatments

Drug: Duloxetine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00989157

F1J-US-X054

Details and patient eligibility

About

This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender.

Enrollment

20 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.