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The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors

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University of Pittsburgh

Status

Completed

Conditions

Gastric Bypass
Anxiety Disorder
Depression

Treatments

Procedure: Roux-en-Y gastric bypass (RYGBP)

Study type

Observational

Funder types

Other

Identifiers

NCT01317147
PRO07120162

Details and patient eligibility

About

The morbidly obese frequently present with mood and anxiety disorders, which are often treated with serotonin reuptake inhibitors (SRI) antidepressant drugs. The investigators hypothesized that gastric bypass surgery would decrease the absorption of SRI. The investigators also wished to determine whether a reduction in SRI levels would increase the likelihood of worsening depressive symptoms.

Full description

Twelve RYGB candidates who were successfully treated with an SRI for primary mood or anxiety disorders were studied prospectively. Blood samples for SRI plasma levels were drawn immediately after dose for pharmacokinetic studies (PK) preoperatively. Maximum concentration (CMAX), time to CMAX (TMAX), and Area Under Concentration/Time curve (AUC) were determined. PK studies were repeated at one, six, and twelve months post-operatively. PK data were corrected for dose at each study time point. The Structured Interview Guide for the Hamilton Depression Rating Scale- Atypical Depression Symptom Version was used to quantify depressive symptoms.

Enrollment

12 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Able to tolerate general anesthesia
  • Able to document prior unsuccessful attempts at weight loss under medical supervision during the last 6 months
  • Able to provide informed consent
  • Cleared for surgery by primary care MD, dietician, and psychiatrist
  • SRI treatment specifically for depression for ≥6 wks at constant dose for last 2 out of 6 wks

Exclusion criteria

  • pregnancy
  • Unwilling or unable to comply with postoperative requirements for diet, supplements, exercise, or followup

Trial design

12 participants in 1 patient group

Gastric bypass patients
Treatment:
Procedure: Roux-en-Y gastric bypass (RYGBP)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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