Clinical Research Studies
SPECIALIZING IN NOVEL AND INNOVATIVE RESEARCH APPROACHES FOR ALL TYPES OF CLINICAL DEPRESSION
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
Tianeptine for Treatment Resistant Depression
Although not available in the United States, Tianeptine is an atypical antidepressant that has been used clinically in Europe, Asia, and South America since the late 1980s in millions of patients. Until recently tianeptine's molecular mechanism of action had remained unknown. Tianeptine is a different type of antidepressant than those currently approved in the United States in that it has a different mechanism of action than other antidepressants.
Eligible participants will receive 8-weeks of treatment with Tianeptine. The major goals of this project are (1) to determine if tianeptine is an effective antidepressant in patients who have failed two previous trials, (2) to define the relationship between opioid signaling deficits and response to tianeptine treatment, and (3) to develop a comprehensive assessment battery capable of identifying endogenous opioid signaling deficits to explore biological heterogeneity in the TRD population.
For further details, please see the following link: https://clinicaltrials.gov/ct2/show/NCT04249596
THERAPEUTIC GROUP FOR WOMEN TRAUMA SURVIVORS
We are conducting a research study on the Building Empowerment and Resilience (BEAR) Therapeutic Group for adult women who have experienced interpersonal trauma. We are recruiting women who would like to participate in the therapeutic group, as well as women who prefer not to participate in the group but are willing to complete a series of questionnaires.
The BEAR Therapeutic group includes psychoeducation, psychological skills, and physical empowerment (self-defense) training. The group will run for 12-weeks, for 1.5 hours once per week. The psychological skills portion of the class will cover topics such as assertiveness, communication skills, and boundary setting. In addition, we will cover basic self-defense techniques one can use to protect themselves if the need arises. This project is focusing on women who have been victims of interpersonal violence (e.g., physical, emotional, or sexual abuse/assault).
To be eligible:
- Women ages 18-70 years old
- History of physical, sexual, or emotional violence with subsequent interpersonal or emotional difficulties related to this history
- Willingness to:
- participate in the BEAR therapy group OR
- to completed a series of questionnaires and not participate in the therapy group
The study is at Stanford University Medical Center during the day. The 12- week program will be provided at no charge or payment to the participants. The study consists of 14 visits: one screening visit, twelve classes, and one debriefing visit. In addition, on-line questionnaires will be completed periodically throughout the study.
For more information, contact us at (650) 724-7184 or email firstname.lastname@example.org.
To fill out a screening for this study, visit https://redcap.link/BEARscreening
All calls/contacts are confidential.
The COMP006 Study
Exploring potential new routes away from treatment-resistant depression
Introducing the COMP 006 clinical study
Many people who receive antidepressant treatment for their depression do not get an adequate response to the medicines they are taking. If someone is taking two or more antidepressants and they are failing, this is sometimes referred to as treatment-resistant depression or TRD.
The COMP 006 study is looking into a new treatment approach for people with TRD using an investigational medicine given with psychological support. The study is suitable for people who have been diagnosed with major depression and are currently experiencing a recurrent or single episode of depression but that have not responded to antidepressant treatment.
You may be eligible to participate in a Compass Pathfinder study if you:
- Are 18 years of age or older
- Have been diagnosed with major depression (single or recurrent episodes)
- Are experiencing treatment-resistant depression, defined as failing 2, 3 or 4 pharmacological treatments for your current episode of depression
- Meet additional study criteria.
About the study
The study, which will last up to 16 weeks, will compare the effectiveness of the active investigational medicine given at different dose levels with psychological support. If you join the study, neither you nor your study doctors will know which study treatment you are going to receive because the decision is made randomly by a computer and not revealed to anyone.
Participants will receive support from study clinicians to help them taper off any prohibited medications, including current antidepressants. Participants will be asked to remain off prohibited medications for the duration of the study.
Reimbursement for reasonable, out-of-pocket expenses for travel and other expenses may be available to qualified individuals.
Enrollment expected to begin early 2024.