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Trial record 41 of 1105 for:    pharmacogenomics OR pharmacogenetics

Comparative Effectiveness of Pharmacogenomics for Treatment of Depression (CEPIO-D)

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ClinicalTrials.gov Identifier: NCT03749629
Recruitment Status : Not yet recruiting
First Posted : November 21, 2018
Last Update Posted : March 11, 2019
Sponsor:
Collaborators:
Genetic Alliance
Patient-Centered Outcomes Research Institute
Vanderbilt University
Montefiore Medical Center
Louisiana State University Health Sciences Center in New Orleans
Duke University
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Andrew A. Nierenberg, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Other: GeneSight Psychotropic test Other: Canadian Network for Mood and Anxiety Treatment (CANMAT) Best Practice Guidelines Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Pharmacogenomics for Treatment of Depression
Estimated Study Start Date : March 29, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: CANMAT + GeneSight Psychotropic Test guided tx
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
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.

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

Placebo Comparator: CANMAT alone
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
Guidelines for treatment




Primary Outcome Measures :
  1. Well-being as assessed by the World Health Organization Well-Being Index (WHO-5) [ Time Frame: 1 year ]
    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).


Secondary Outcome Measures :
  1. Depression severity [ Time Frame: 1 year ]
    Patient Health Questionnaire (PHQ-9)- The Patient Health Questionnaire-9 (PHQ-9) is a brief self-report instrument used to screen, diagnose, monitor, and measure the severity of depression. The first 8 questions incorporate DSM-IV diagnostic criteria as well as other major depressive symptoms, and Question 9 assesses for the presence and duration of suicidal ideation.

  2. Necessary medication adjustments [ Time Frame: 1 year ]
    Medication Recommendation Tracking Form (MRTF) Study clinicians will use this online medication tracking form that we have used in our previous large-scale, clinical trials conducted on the Bipolar Trials Network to record the dates of starting and stopping psychotropic medications as well as the reasons for discontinuation.

  3. Functioning [ Time Frame: 1 year ]
    Patient-Reported Outcomes Measurement Information System (PROMIS) Functioning Functioning will be measured via the PROMIS 29Ability to Participate in Social Roles and Activities" Index. This scale consists of 4 items that inquire about a person's ability to do leisure or family activities, perform usual work activities (including work at home), or engage in desired activities with friends in the past 7 days. Items are rated on a 5-point rating scale ranging from "Never" to "Always", resulting in a range of scores from "0" to "20", with "0" indicating maximum impairment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • Patients with a history of gastric bypass surgery. (This exclusion depends on the type of gastric bypass surgery. Those that simply restrict the size of the stomach are acceptable.
  • 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

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): NCT03749629


Contacts
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Contact: Selen Amado, BA 6177267531 samado2@mgh.harvard.edu

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

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Responsible Party: Andrew A. Nierenberg, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03749629     History of Changes
Other Study ID Numbers: 2018P002499
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew A. Nierenberg, MD, Massachusetts General Hospital:
Depression
Major Depressive Disorder
Pharmacogenomic testing
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Psychotropic Drugs