Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder

Depression Clinical Trial

Official title:

Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03537547
• Other study ID #: 201609109
• Status: Terminated
• Phase: Phase 4
• Start date: May 4, 2018
• Est. completion date: August 19, 2019

Study information

• Verified date: June 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to determine whether the GeneSight Psychotropic test can result in better treatment outcomes for patients with treatment-naive major depressive disorder

Description:

Major Depressive Disorder is a chronic psychiatric illness that leads to devastating consequences at the individual and societal levels. Today, the choice of treatment continues to be largely based on subjective factors, primarily the clinician and/or patient's preferences, as well as the individual's history of response to treatment, often tainted by recall bias. Psychiatric medication decisions are even more arbitrary when the subject in question has not had past treatment trials. This often leads to a trial and error process and an increasingly resistant disease with each failed trial. Early implementation of an objective tool designed for tailoring medication choice to an individual may prove highly beneficial in decreasing illness chronicity, individual suffering, and economic burden.

GeneSight Psychotropic test is a pharmacogenomic decision support tool, developed to help clinicians make informed, evidence-based decisions about proper drug selection. Therefore, we propose conducting a randomized, double blind, controlled trial to evaluate the impact of the GeneSight Psychotropic test to guide treatment decisions in patients with treatment-naïve (never having taken medication for depression) Major Depressive Disorder.

This study will involve 6 visits over about 24 weeks where participants will be randomized to have their study clinician have access to their pharmacogenetic report in order to make treatment decisions, or to not have access to their report for the first 12 weeks. At Visit 5, Week 12, all participants will receive a copy of their pharmacogenetics report and all clinicians will be unblinded to be able to use the results to guide treatment options for an additional 12 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Adults 18-65 years of age

2. Treatment-naïve major depressive disorder meeting Diagnostic and Statistical Manual 4th Edition (DSM-IV) criteria, without psychosis

3. Total baseline score on the Quick Inventory Of Depressive Symptomatology Clinician-rated (QIDS-C16) and the Quick Inventory Of Depressive Symptomatology Self-Report (QIDS-SR16) rating scale =11

4. Good command of the English language

Exclusion Criteria:

1. Patients with a current diagnosis of schizophrenia

2. Patients with a current diagnosis of schizoaffective disorder

3. Patients with a current diagnosis of bipolar disorder (any type)

4. Currently meeting DSM-IV criteria for significant substance use disorder (exception:

nicotine use disorder)

5. A diagnosis of personality disorder that may interfere with the patient's ability to improve on pharmacologic treatment, as determined by study investigator

6. Patients currently receiving electroconvulsive therapy(ECT), deep brain stimulation (DBS) or transcranial magnetic stimulation (TMS) treatment

7. History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months

8. Significant unstable medical condition; life threatening disease; hepatic insufficiency; 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; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications

9. History of gastric bypass surgery

10. Acute suicidal intention and/or in need of immediate hospitalization as judged by the investigator

11. Active psychotic symptoms

12. Currently in an inpatient facility

13. History of prior pharmacogenomic testing

14. Currently pregnant or lactating

15. Inability to provide informed consent

16. Any other factor that in the investigators' judgment may affect patient safety or compliance

Related Conditions & MeSH terms

• Depression
• Depression, Unipolar
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Episode
• Disease
• Major Depressive Disorder

Intervention

Other:
• GeneSight Psychotropic test
GeneSight Psychotropic test, developed by AssureRx Health, is a genetic test that analyses pre-selected pharmacokinetics and pharmacodynamics genes and results in a composite phenotype and interpretive report, addressing both safety and efficacy of psychiatric medications.

Drug:
• FDA-approved antidepressant or antipsychotic treatment
Participant is treated with medications included in the GeneSight Psychotropic product.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	AssureRx Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression change score- Week 8	17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. Total range of the Hamilton Rating Scale for Depression is 0 to 52, with a greater score being an indication of more severe depressive symptoms.	Baseline to Week 8
Secondary	Hamilton Rating Scale for Depression change score- Week 4	17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. Total range of the Hamilton Rating Scale for Depression is 0 to 52, with a greater score being an indication of more severe depressive symptoms.	Baseline to end of week 4
Secondary	Hamilton Rating Scale for Depression change score- Week 12	17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. 17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. Total range of the Hamilton Rating Scale for Depression is 0 to 52, with a greater score being an indication of more severe depressive symptoms.	Baseline to end of week 12
Secondary	Hamilton Rating Scale for Depression change score- Week 24	17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. 17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. Total range of the Hamilton Rating Scale for Depression is 0 to 52, with a greater score being an indication of more severe depressive symptoms.	Baseline to end of week 24