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Venlafaxine PK Following Bariatric Surgery (VLX)

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ClinicalTrials.gov Identifier: NCT02005107
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
Neuropsychiatric Research Institute, Fargo, North Dakota
Information provided by (Responsible Party):
Kristine Steffen, North Dakota State University

Brief Summary:
This study is being conducted to evaluate how the body absorbs and processes the immediate release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are 1-3 years post gastric bypass or sleeve gastrectomy surgery will be invited to participate. Non-surgical controls will also be enrolled based on a matching criteria to post gastric bypass subjects. Participants will be asked to complete two 12-hour study days approximately 11 days apart. This study will enroll up to 30 participants.

Condition or disease Intervention/treatment Phase
Roux en Y Gastric Bypass Sleeve Gastrectomy Drug: Venlafaxine IR and Venlafaxine XR Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Comparison of Immediate and Extended Release Venlafaxine Following Bariatric Surgery
Study Start Date : December 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: venlafaxine
Venlafaxine IR and XR, single dosages of each separated by a wash-out period
Drug: Venlafaxine IR and Venlafaxine XR
Other Name: Effexor and Effexor XR

Venlafaxine XR and Venlafaxine IR
Each participant (3 groups of participants) will receive one dose of venlafaxine IR and one dose of venlafaxine XR seperated by a wash-out period.
Drug: Venlafaxine IR and Venlafaxine XR
Other Name: Effexor and Effexor XR




Primary Outcome Measures :
  1. Venlafaxine Plasma Concentrations/Area-Under-the-Curve (AUC) [ Time Frame: 24 hours intervals ]
    The primary aim of this research is to provide a comparison of pharmacokinetic measures associated with a single dose of venlafaxine IR (immediate release) and venlafaxine XR (sustained release) in Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, and matched nonsurgical "control" subjects. Comparisons will be based upon venlafaxine plasma concentrations obtained during the 24 hour sample collection window.


Secondary Outcome Measures :
  1. Secondary PK Characteristics (Composite) [ Time Frame: 24 hour collection ]
    We will also evaluate other PK characteristics associated with venlafaxine, such as Cmax, Tmax, t1/2, and the ratio of venlafaxine to the active metabolite ODV, and others.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or Female
  2. Age 18-65 (inclusive, at time of informed consent)
  3. No tobacco use in the past three months.
  4. Underwent Roux-en-Y Gastric Bypass or Sleeve Gastrectomy weight loss surgery 12-36 months prior to study OR has not had a weight loss surgery but matches the gastric bypass patients on age, gender, and BMI. Criteria for matching will be established at the beginning of the study in consultation with the statistical team and addressed as needed with the input of the biostatistician.
  5. Ability to read, write and understand English

Exclusion Criteria:

  1. Taking a medication that has a clinically significant interaction with venlafaxine or an interaction that may alter the study data.
  2. Hypersensitivity to venlafaxine or any excipient contained within the dosage forms
  3. Inability to tolerate repeated blood draws.
  4. Any history of bipoloar disorder or a psychotic disorder.
  5. Current major depressive disorder or current suicidality.
  6. Alcohol or substance dependence in the past year.
  7. Currently pregnant or lactating or unwillingness to use medically accepted contraception during study
  8. Taking a medication which significantly alters gastrointesinal transit time or significantly reduces acid secretion (e.g. routine use of proton pump inhibitors, H2 antagonists, sucralfate).
  9. Medical conditon which may increase participant risk with venlafaxine or uncontrolled hypertension at the discretion of the examining provider.
  10. Hepatic insufficiency as defined by any hepatic enzyme greater than 3x the upper limit of normal or other hepatic laboratory abnormalities at the discretion of the medical provider.
  11. Renal impairment as evidence by a calculated creatinine clearance of less than or equal to 70ml/min or other abnormality on a renal panel that the medical provider feels puts the participant at risk.
  12. Poor or ultra-rapid Cytochrome P450 2D6 metabolizer.
  13. Self reported history of viral hepatits or HIV.
  14. Positive urine drug screen unless documented prescription of a non-interacting medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005107


Locations
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United States, North Dakota
Neuropsychiatric Research Institute
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
North Dakota State University
Neuropsychiatric Research Institute, Fargo, North Dakota
Investigators
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Principal Investigator: Kristine J Steffen, Pharm.D., Ph.D. North Dakota State University & Neuropsychiatric Research Institute

Additional Information:
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Responsible Party: Kristine Steffen, Associate Professor, North Dakota State University, North Dakota State University
ClinicalTrials.gov Identifier: NCT02005107     History of Changes
Other Study ID Numbers: KSteffenVLX
EPSCOR ( Other Identifier: North Dakota State University )
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
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Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs