Pharmacogenomic Testing in Major Depressive Disorder

October 10, 2022 updated by: Columbia University

Impact of Comprehensive Pharmacogenomic Testing on the Treatment of Major Depressive Disorder

This is a two-arm double-blind prospective randomized controlled trial (RCT) to evaluate clinical impact of pharmacogenomic testing on the treatment of major depressive disorder. Participants will be randomly assigned to two groups: pharmacogenomic-guided therapy group (guided group) and treatment as usual group (TAU group). The primary hypothesis is the pharmacogenomic-guided treatment group will demonstrate significantly higher percent improvement in depression score compared to treatment-as-usual group.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

To a large extent, variability in antidepressant efficacy can be explained by genetic variations that affect medication-metabolizing enzymes, drug transporters, and medication targets. Recent reviews demonstrated significant potential of pharmacogenomic testing in improving treatment of major depressive disorder. One of the major barriers towards successful implementation of pharmacogenomic testing for patients with major depressive disorder is lack of systematic evaluation of impact of this approach in routine clinical care settings. The major goal of this study is to systematically evaluate impact of comprehensive pharmacogenomic testing on the treatment of major depressive disorder in ambulatory setting.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Clinical diagnosis of major depressive disorder (MDD)
  2. Prescription of index antidepressant medications
  3. Minimum score of 14 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)

Exclusion Criteria:

  1. Diagnosis of bipolar disorder (any type), schizophrenia, or schizoaffective disorders
  2. Active diagnosis of substance abuse or dependence
  3. Current suicidal ideation
  4. Previous suicidal attempts
  5. A person has already had pharmacogenetic testing done.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacogenomic-guided therapy group
In this group, results of pharmacogenomic testing will be provided to the treating physician within 2-5 working days. Thus, the patient's treatment provider will be able begin antidepressant adjustments based on pharmacogenomic testing report within a week of the baseline visit.
Other: Pharmacogenomic testing
Pharmacogenomic testing is delivered to treating providers of patients with major depressive disorder
No Intervention: Treatment as usual (TAU) group
For patients randomized to this group, medication treatment decisions by the treating clinicians will be made without the availability of the pharmacogenomic report; however, the test results will be provided after the study completion to the patient treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on the Hamilton Rating Scale for Depression (HAMD-17)
Time Frame: Up to 10 weeks
The patient is rated by a clinician among 17 dimensions with a score on a 3 or 5 point scale. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial.
Up to 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on Subject-Rated 16-item Quick Inventory of Depression Symptomatology Scales (QIDS-SR)
Time Frame: Up to 10 weeks
The Quick Inventory of Depressive Symptomatology is a short screening tool based on the larger Inventory of Depressive Symptomatology (IDS). Each item is scored on a scale from 0 to 3 points. Total scores range from 0 (no depression) to 27 (severe depression).
Up to 10 weeks
Score on the 9-item Patient Health Questionnaire (PHQ-9)
Time Frame: Up to 10 weeks
The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Higher PHQ-9 scores are associated with decreased functional status and increased symptom-related difficulties, sick days and healthcare utilization.
Up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Manuel Cabrera, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

July 17, 2019

Study Completion (Actual)

July 17, 2019

Study Registration Dates

First Submitted

July 21, 2017

First Submitted That Met QC Criteria

July 21, 2017

First Posted (Actual)

July 25, 2017

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAR4283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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