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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01317147

Enrollment

Registered

2011-03-17

Start date

2007-08-31

Completion date

2010-08-31

Last updated

2011-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Bypass, Depression, Anxiety Disorder

Keywords

pharmacokinetics, serotonin reuptake inhibitors, gastric bypass, depression, bioavailability, drug absorption, area under curve

Brief summary

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.

Detailed 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.

Interventions

PROCEDURERoux-en-Y gastric bypass (RYGBP)

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026