Clinical trial

Bariatric Surgery and Pharmacokinetics Quetiapine: BAR-MEDS Quetiapine

Name

2016/1145a

Description

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on quetiapine are investigated.

Trial arms

Trial start

2018-01-02

Estimated PCD

2026-10-01

Trial end

2026-10-01

Status

Recruiting

Treatment

Quetiapine

Patients are tested for their normal prescription quetiapine medication

Other names:

Quetiapine fumarate

Size

Primary endpoint

Quetiapine concentration in blood serum (area under curve (AUC))

From baseline to 1 year postoperatively

Eligibility criteria

Inclusion Criteria: * Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway * Being a Norwegian citizen Exclusion Criteria: * Having previously undergone resections in the GI-tract

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

Updated at

2023-03-27

1 organization

1 product

2 indications

Organization

Norwegian University of Science and Technology

Product

Quetiapine

Indication

Obesity

Indication

Morbid