Comparative Effectiveness of Pharmacogenomics for Treatment of Depression

NCT03749629 | Completed DMC

• 1 other identifier: 2018P002499
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to assess the effectiveness of a widely available and widely used combinatorial pharmacogenomic (PGx) test for the treatment of major depressive disorder. Pharmacogenomic tests use genetic information to guide medication treatment decisions. The tests inform clinicians and patients of potential gene-drug interactions by analyzing pharmacokinetic (PK) genes (how drugs are metabolized) as well as pharmacodynamic (PD) genes (how drugs work). While combinatorial PGx testing is attractive to clinicians, patients, healthcare systems, and insurers, limited data demonstrate that PGx testing will result in better outcomes compared to evidence-based guideline treatment. Therefore, the investigators will conduct a prospective randomized comparative effectiveness study of best practice guidelines plus combinatorial PGx-guided treatment versus best-practice guideline concordant treatment alone.

Conditions

Major Depressive Disorder

Keywords

Depression; Major Depressive Disorder; Pharmacogenomic testing

Outcome Measures

Primary Outcomes (1)

• Well-being as assessed by the World Health Organization Well-Being Index (WHO-5)

  Hypothesis: Combinatorial PGx-guided treatment will be superior to best-practice guideline treatment to increase well-being The World Health Organization-5 Well-Being Index (WHO-5, primary outcome measure) is a brief 5-item self-report questionnaire consisting of positively-worded statements related to positive mood, vitality, and general interests over the prior two weeks. Item scores range from 0 (none of the time) to 5 (all of the time), resulting in a range of summary scores from 0 (poor well-being) to 25 (optimal well-being).

  1 year

Secondary Outcomes (3)

• Depression severity

  1 year

• Necessary medication adjustments

  1 year

• Functioning

  1 year

Study Arms (2)

CANMAT + GeneSight Psychotropic Test guided tx

ACTIVE COMPARATOR

Participant treatment will be guided by the Canadian Network for Mood and Anxiety Treatments (CANMAT) and the pharmacogenomic test GeneSight®. GeneSight® is a neuropsychiatric, combinatorial, PGx test that provides recommendations for psychotropic medications (antidepressants, mood stabilizers, hypnotics for insomnia, and antipsychotics) based on a patient's individual genetic profile.

Other: GeneSight Psychotropic test; Other: Canadian Network for Mood and Anxiety Treatment (CANMAT) Best Practice Guidelines

CANMAT alone

PLACEBO COMPARATOR

Participant treatment will be guided by the Canadian Network for Mood and Anxiety Treatments (CANMAT) alone.

Other: Canadian Network for Mood and Anxiety Treatment (CANMAT) Best Practice Guidelines

Interventions

GeneSight Psychotropic test OTHER

GeneSight® Psychotropic powered by CPGx® technology, the only test for depression reimbursable by Medicaid and Medicare. GeneSight® is a neuropsychiatric, combinatorial, PGx test that provides recommendations for psychotropic medications (antidepressants, mood stabilizers, hypnotics for insomnia, and antipsychotics) based on a patient's individual genetic profile.

CANMAT + GeneSight Psychotropic Test guided tx

Canadian Network for Mood and Anxiety Treatment (CANMAT) Best Practice Guidelines OTHER

Guidelines for treatment

CANMAT + GeneSight Psychotropic Test guided tx; CANMAT alone

Eligibility Criteria

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

You may qualify if:

• Ability to give informed consent
• Between the ages of 18-65
• Diagnosed with Major Depressive Disorder (assessed by the Composite International
• Diagnostic Interview Screening Scales (CIDI-SC))
• Currently Depressed (PHQ 9 ≥10)

You may not qualify if:

• Diagnosis of bipolar disorder or schizophrenia
• Patients posing a serious suicidal risk and/or in need of immediate hospitalization as judged by the treating clinician
• Has a general medical condition that is responsible for depressive symptoms or uses a medication responsible for depressive symptoms
• Any medical contraindications for participants to take study medications
• Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months
• Patients with significant unstable medical condition; life threatening disease; hepatic insufficiency (3X Upper Limit of Normal (ULN) for AST and/or ALT); liver transplant recipient; cirrhosis of the liver; need for therapies that may obscure the results of treatment and/or of the study; malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening
• Those that alter the ability of the stomach/digestive lining to absorb nutrients are not. GeneSight is unable to account for absorption issues due to this reason at this time.)
• Patients who self-report to be pregnant or lactating

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Genetic Alliance: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• Vanderbilt University: collaborator
• Montefiore Medical Center: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator
• Duke University: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Investigators will prospectively randomize 400 participants with DSM-V major depressive disorder to best practice guidelines plus PGx- guided psychiatric treatment (n=200) or best practice guidelines alone (n=200) and follow them for one year.

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 21, 2018
• Study Start: May 1, 2019
• Primary Completion: March 10, 2021
• Study Completion: March 15, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)