Pharmacogenomic Testing in Major Depressive Disorder

NCT ID: NCT03228953

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-07-17

Brief Summary

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.

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pharmacogenomic testing

Intervention Type: OTHER

Pharmacogenomic testing is delivered to treating providers of patients with major depressive disorder

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pharmacogenomic testing

Pharmacogenomic testing is delivered to treating providers of patients with major depressive disorder

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuel Cabrera, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAR4283

Identifier Type: -

Identifier Source: org_study_id