- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03228953
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
-
-
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:
- Clinical diagnosis of major depressive disorder (MDD)
- Prescription of index antidepressant medications
- Minimum score of 14 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)
Exclusion Criteria:
- Diagnosis of bipolar disorder (any type), schizophrenia, or schizoaffective disorders
- Active diagnosis of substance abuse or dependence
- Current suicidal ideation
- Previous suicidal attempts
- 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.
|
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
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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