Clinical Research Studies
SPECIALIZING IN NOVEL AND INNOVATIVE RESEARCH APPROACHES FOR ALL TYPES OF CLINICAL DEPRESSION
***Due to current Covid-19 regulations, some studies are currently enrolling via televisits. We will be reviewing new applicants and enrolling when permitted. Please be aware that response times may be greater than usual during this time. ***
Currently Enrolling Studies
RELIANCE-II: A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder.
Eligible participants will either receive the study drug, REL-1017, or placebo. Esmethadone (also known as dextromethadone) is the active ingredient in REL-1017 tablets. This study drug selectively works on nerve cells that seem to play a role in depression. A placebo is an inactive tablet that looks identical to the study drug (tablet) but does not contain the active study drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing.
The main goals of this study are to learn how safe the study drug is and how well the study drug works when taken with the antidepressants you are currently taking for MDD.
For further details, please see the following link: https://clinicaltrials.gov/ct2/show/NCT04855747
Opiate Suicide Study in Patients with Major Depression
We are doing this study to determine if suicidal thoughts are lessened after an infusion of ketamine followed by 4 weeks of a medication called buprenorphine. Participants for this research will be currently experiencing depression and will have not responded to treatment with antidepressants or have an intolerance to these types of medicines. Recent studies have shown a single infusion of ketamine to reduce suicidal ideation within 24 hours and to last for at least one week. We would like to determine if a single infusion of ketamine followed by 4 weeks of low dose burprenorphine produces longer lasting anti-suicidal effects than does ketamine followed by placebo.
This research study is expected to take approximately 2 years to complete with at least 6 weeks of active participation by each participant. During this time, participants will make 10 study visits to Stanford University, including an 8-hour infusion visit.
Under the close supervision and monitoring by the study clinicians, eligible subjects will receive a single infusion of ketamine 0.5mg/kg followed by oral buprenorphine or placebo for 4 weeks.
This research study will use either Buprenorphine or a placebo, containing no drug, to study if the benefits experienced from Ketamine can be improved or last longer when buprenorphine is taken for 4 weeks.
For further details, please see the following link: https://clinicaltrials.gov/ct2/show/NCT04116528