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NCT02165449 · ClinicalTrials.gov registry record · Phase 1
Biomarkers of Fast Acting Therapies in Major Depression
A Phase 1 study of Major Depressive Disorder, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT02165449 is a Phase 1 study of Major Depressive Disorder that has completed, run by University of California, Los Angeles. The registered enrollment target is 60 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02165449, a Phase 1 study of Major Depressive Disorder, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The drug Ketamine, available in medical practice since the late 1960s, is currently used for inducing general anesthesia or sedation during medical procedures. When given slowly as an injection into a vein, ketamine is shown to produce a very rapid effect on depression and to improve depressive symptoms within hours to days. By studying patients who receive a ketamine IV infusion, as an add-on treatment for depression, investigators may start to understand how changes in the brain or in gene function relate to getting better over a very short period of time. In this study, the investigators will enroll 60 patients currently ill with major depression selected to receive IV ketamine therapy under medical supervision. To study neurobiological changes relating to symptom improvement, the investigators will use advanced brain scans to measure brain structure, chemistry and function. Blood samples will measure changes in gene regulation and immune system response. Although some people have a rapid antidepressant response to ketamine, others do not respond. Also, antidepressant effects after ketamine usually wear off within days to weeks. We will determine if up to four doses of ketamine delivered two to three times a week may prolong antidepressant response to ketamine therapy. To determine the durability of ketamine treatment for depression, patients will be monitored by phone and via electronic devices twice a week for up to five weeks and will return for a final assessment when their symptoms return. For this trial, brain and blood sample measurements will occur before and after a patient receives their first ketamine infusion. Patients who do not remit after an initial dose of ketamine, will receive up to three additional ketamine treatments. Mood will be measured 24-hours after each subsequent ketamine infusion and brain and blood measurements be repeated at the time of remission or after the fourth ketamine infusion if remission does not occur. Patients will return
Conditions Studied
Interventions
- DRUG Ketamine
Study Locations (1)
California
- Geffen School of Medicine, UCLA - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-06 |
| Est. Completion | 2019-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02165449
The ClinicalTrials.gov registry entry for NCT02165449 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (84% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Ketamine is the first listed.
NCT02165449 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT02165449 about?
NCT02165449 is a clinical study titled "Biomarkers of Fast Acting Therapies in Major Depression". The drug Ketamine, available in medical practice since the late 1960s, is currently used for inducing general anesthesia or sedation during medical procedures. When given slowly as an injection into a vein, ketamine is shown to produce a very rapid effect on depression and to improve depressive symp...
What is the current status of trial NCT02165449?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2014-06. Estimated completion is 2019-08.
What conditions does trial NCT02165449 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT02165449?
The interventions under investigation include: Ketamine (DRUG).
Who is sponsoring clinical trial NCT02165449?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02165449 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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