Genecept Assay and Adverse Effects of Antidepressants

NCT02883660 | Completed

• 1 other identifier: 13P.25
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether patients who have been prescribed antidepressant medications and have experienced significant adverse effects are more likely to be poor metabolizers on the CYP450 (CYP2B6, CYP2D6, CYP2C19, CYP3A4/5+) drug metabolizing enzymes and/or homozygous for the short allele of the serotonin transporter (SLC6A4) compared to patients who took an antidepressant medication and did not experience significant adverse effects but also had minimal or no response to the medication. The target medications being studied include escitalopram, citalopram, paroxetine, fluvoxamine, venlafaxine, duloxetine, bupropion, vortioxetine, vilazodone, and levomilnacipran only.

Conditions

Depression; Adverse Effects

Keywords

genetics; Antidepressants

Outcome Measures

Primary Outcomes (2)

• Poor metabolizers have more side effects

  Our primary aim is to test the hypothesis that a statistically significantly higher proportion of Cases than Controls will be poor metabolizers on CYP450 isoenzymes (CYP2B6, CYP2D6, CYP2C19, CYP3A4/5+).

  through study completion, approximately 2 years

• Homozygenous for short allele of SLC6A4 will result in more side effects

  Our co-primary aim is to test the hypothesis that a statistically significantly higher proportion of Cases than Controls will be homozygenous for the short allele of SLC6A4.

  through study completion, approximately 2 years

Study Arms (2)

Cases

patients who had empirically defined "increased AEs" on one of the specified antidepressants (SSRIs/ SNRIs). This group will get the Genecept Assay, which is a battery of pharmacogenetic tests relevant to psychiatry.

Genetic: Genocept Assay

Controls

patients who did not have empirically defined "increased AEs" with an index antidepressant (one of the specified SSRIs/ SNRIs) AND were "nonresponders" to that antidepressant. This group will get the Genecept Assay, which is a battery of pharmacogenetic tests relevant to psychiatry.

Genetic: Genocept Assay

Interventions

Genocept Assay GENETIC

battery of pharmacogenetic tests relevant to psychiatry

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

One hundred (100) subjects aged 18 years or older, currently or in the past on one of the target antidepressants, will be recruited into this study.

You may qualify if:

• Age 18 years or older
• Able to give informed consent prior to the initiation of any protocol required procedures.
• Subject must be able to understand the nature of the study, agree to comply with the study procedures, and communicate about medical history to the study personnel.
• Subject was treated with one of the following "target antidepressants:" Escitalopram, citalopram, paroxetine, fluvoxamine, venlafaxine, duloxetine, bupropion, vortioxetine, vilazodone, and levomilnacipran. Rationale: These antidepressants are primarily metabolized by CYP isoenzymes that will be assessed. Antidepressants like sertraline, fluoxetine, and mirtazapine are metabolized by multiple CYP isoenzymes and therefore are less likely to be significantly affected by metabolizer status on a particular CYP isoenzyme. For patients who have been treated with multiple antidepressants, the antidepressant that was associated with the greatest overall burden of AEs will be selected as the target antidepressant.
• a. Study group: "Increased AEs" currently or in the past on one of the target antidepressants as operationally defined as either A or B: A) One or more AEs that were moderate/severe OR three or more AEs that were mild occurring on less than the usual minimum recommended dose of the antidepressant, or B) Three or more AEs that were moderate/severe OR five or more AEs that were mild on a dose of the antidepressant within the usual recommended dose 5b. Control group: Both A and B A. Less than 30% reduction in the severity of depression after treatment for at least 6 weeks B. Minimal or no AEs on that antidepressant

You may not qualify if:

• Subjects for whom it is unclear which medication caused the adverse events
• Subjects for whom participation in the study would be detrimental to their mental of physical health based on investigator's opinion
• Subjects who have had a medical condition that, in the investigator's judgment, may be causing the reported adverse events
• Prisoners or patients who are involuntarily incarcerated

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• William Jangro, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: August 30, 2016
• Study Start: February 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: February 1, 2018
• Last Updated: March 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)