## Protocol Section
### Identification Module
**NCT ID:** NCT03460379

**Brief Title:** Bariatric Surgery and Pharmacokinetics of Escitalopram

**Official Title:** Bariatric Surgery and Pharmacokinetics Escitalopram: BAR-MEDS Escitalopram

#### Organization Study ID Info
**ID:** 2016/1145k
#### Organization
**Class:** OTHER
**Full Name:** Norwegian University of Science and Technology
### Status Module
#### Completion Date
**Date:** 2026-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-03-27

**Type:** ACTUAL

**Last Update Submit Date:** 2023-03-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-11-02

**Type:** ACTUAL

**Status Verified Date:** 2023-03

#### Study First Post Date
**Date:** 2018-03-09
**Type:** ACTUAL
**Study First Submit Date:** 2018-03-04
**Study First Submit QC Date:** 2018-03-04
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** St. Olavs Hospital

**Class:** OTHER

**Name:** Volvat Medisinsk Senter Stokkan

**Class:** OTHER

**Name:** Namsos Hospital

**Class:** OTHER

**Name:** Alesund Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Norwegian University of Science and Technology

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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 escitalopram are investigated.

### Conditions Module

**Conditions:**

- Obesity, Morbid

**Keywords:**

- Bariatric surgery

- Gastrointestinal tract

- Biological availability

- Pharmacokinetics

- Citalopram

### Design Module

#### Bio Spec

**Description:** Blood

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 12

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Patients are tested for their normal prescription escitalopram medication

**Name:** Escitalopram

**Other Names:**

- Citalopram

- Cytalopram

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Escitalopram concentration in blood serum (area under curve (AUC))

**Time Frame:** From baseline to 1 year postoperatively

### Eligibility Module

**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

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** magnus.strommen@stolav.no

**Name:** Magnus Strømmen, MSc

**Phone:** 0047 72829970

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Trondheim

**Contacts:**

***Contact 1:***

- **Name:** Magnus Strømmen, MSc

- **Role:** CONTACT

**Country:** Norway

**Facility:** St. Olavs University Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** St. Olavs University Hospital

**Name:** Magnus Strømmen, MSc

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009765

- Term: Obesity

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M12702

- Name: Obesity, Morbid

- Relevance: HIGH

- As Found: Obesity, Morbid

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009767

- Term: Obesity, Morbid

### Intervention Browse Module - Ancestors

- ID: D000017367

- Term: Selective Serotonin Reuptake Inhibitors

- ID: D000014179

- Term: Neurotransmitter Uptake Inhibitors

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000018490

- Term: Serotonin Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018687

- Term: Antidepressive Agents, Second-Generation

- ID: D000000928

- Term: Antidepressive Agents

- ID: D000011619

- Term: Psychotropic Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnDyAg

- Name: Anti-Dyskinesia Agents

### Intervention Browse Module - Browse Leaves

- ID: M17983

- Name: Citalopram

- Relevance: HIGH

- As Found: Valsartan

- ID: M2732

- Name: Escitalopram

- Relevance: HIGH

- As Found: Enrollment

- ID: M7104

- Name: Dexetimide

- Relevance: LOW

- As Found: Unknown

- ID: M19649

- Name: Selective Serotonin Reuptake Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000015283

- Term: Citalopram

- ID: D000089983

- Term: Escitalopram

### Misc Info Module

- Version Holder: 2024-05-24
