Pharmacogenomic Testing in Major Depressive Disorder

NCT03228953 | Terminated

• 1 other identifier: AAAR4283
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Pharmacogenomic testing; Depression

Outcome Measures

Primary Outcomes (1)

• Score on the Hamilton Rating Scale for Depression (HAMD-17)

  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 Outcomes (2)

• Score on Subject-Rated 16-item Quick Inventory of Depression Symptomatology Scales (QIDS-SR)

  Up to 10 weeks

• Score on the 9-item Patient Health Questionnaire (PHQ-9)

  Up to 10 weeks

Study Arms (2)

Pharmacogenomic-guided therapy group

EXPERIMENTAL

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

Treatment as usual (TAU) group

NO INTERVENTION

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.

Interventions

Pharmacogenomic testing OTHER

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

Pharmacogenomic-guided therapy group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Manuel Cabrera, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 25, 2017
• Study Start: August 1, 2017
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)