Treatment Resistant Depression Study
Sheppard Pratt is looking into a new investigational treatment approach for people with treatment-resistant depression.
Fast Facts
Diagnosed with Depression
Have not responded to Antidepressants
Do not have Uncontrolled High Blood Pressure
Conducted in the greater Baltimore Metropolitan Area
Study Background
Learn more about a study looking at a new investigational treatment approach for treatment-resistant depression using an investigational medicine alongside psychological support.
Many people who receive antidepressant treatment for their depression do not get an adequate response to these treatments. This is sometimes referred to as treatment-resistant depression or TRD.
This study will explore whether an investigational medicine, COMP360, together with psychological support, is an effective treatment for people who have not been helped by prior treatments for their depression.
Study Background
Learn more about a study looking at a new investigational treatment approach for treatment-resistant depression using an investigational medicine alongside psychological support.
Many people who receive antidepressant treatment for their depression do not get an adequate response to these treatments. This is sometimes referred to as treatment-resistant depression or TRD.
This study will explore whether an investigational medicine, COMP360, together with psychological
support, is an effective treatment for people who have not been helped by prior treatments for their depression.
Additional Information
The COMP 005 study is trying to find out whether an investigational medicine, given with psychological support, can improve depressive symptoms for those who have treatment-resistant depression (TRD).
You may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- Diagnosed with depression
- Have tried 2 or more antidepressant medications for your current depressive episode and continue to have depressive symptoms
- Do not have uncontrolled high blood pressure/hypertension
- Have not used psychedelics in current episode of depression
- Ages 18+
The study is comprised of three parts, beginning with a 6-week single-dose, randomized phase where participants will be placed into a group that receives either active drug or a placebo (Part A).
This is followed by a 20-week follow-up phase with an opportunity for re-treatment within the same treatment groups (Part B). Participants who do not qualify for re-treatment or decline re-treatment will be seen monthly to monitor safety and depressive status.
The last phase, which lasts 26 weeks, will offer participants who qualify and have not seen significant improvement in their depression, or have seen improvement and then relapsed, a chance to receive a guaranteed dose of 25mg of COMP360 alongside psychological support (Part C).
In total, study participation lasts roughly 12-14 months.
There is no payment for study participation; however, reimbursement for study travel is available.
There is no cost for you to participate in our research study.
