NCT03537547|TerminatedPhase 4
Study Stopped
Per sponsor and PI institution discussions
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Sponsor study identifier
interventional
6
1 country
1
Study Start
May 4, 2018
Actual (reported)Primary Completion
August 19, 2019
Actual (reported)Study Completion
August 19, 2019
Actual (reported)This study aims to determine whether the GeneSight Psychotropic test can result in better treatment outcomes for patients with treatment-naive major depressive disorder
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 19, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 4, 2018
Actual (reported)May 15, 2018
Actual (reported)May 25, 2018
Actual (reported)August 19, 2019
Actual (reported)August 19, 2019
Actual (reported)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
Hamilton Rating Scale for Depression change score- Week 4
Baseline to end of week 4
Hamilton Rating Scale for Depression change score- Week 12
Baseline to end of week 12
Participants randomized to have their study clinician have access to their pharmacogenetic report (provided through the GeneSight Psychotropic tool) in order to make treatment decisions for the first 12 weeks. At Visit 5, Week 12, participants will receive a copy of their pharmacogenetics report and clinicians will continue to be able to use the results to guide treatment options for an additional 12 weeks.
Participants randomized to treatment as usual will receive treatment from study clinicians who do not have access to the participant's report for the first 12 weeks. At Visit 5, Week 12, participants will receive a copy of their pharmacogenetics report and clinicians will be unblinded to be able to use the results to guide treatment options for an additional 12 weeks.
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.
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Charles Conway, MD
Washington University School of Medicine
6 participants (actual enrollment reported by the registry).
First Submitted
May 15, 2018
First Posted
Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder
Hamilton Rating Scale for Depression change score- Week 24
Baseline to end of week 24
Participant is treated with medications included in the GeneSight Psychotropic product.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
May 25, 2018
Study Start
May 4, 2018
Actual (reported)Primary Completion
August 19, 2019
Actual (reported)Study Completion
August 19, 2019
Actual (reported)Last Updated
June 5, 2020
Record last verified: 2020-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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