Intranasal 5-MeO-DMT for Treatment-Resistant Depression (TRD)

Treatment resistant depression (TRD) is a serious medical illness that affects approximately 30-40% of patients with Major Depressive Disorder. TRD is associated with a significantly lower quality of life and is defined by a failure to respond to an adequate dose and duration of at least two (2) medicines for depressive symptoms. Psychedelic-assisted therapy is an alternative treatment to traditional antidepressant medications and other established forms of therapy. The study medication BPL-003 contains 5-MeO-DMT, a naturally occurring psychedelic compound found in a number of plants and fungi, as well as in the secretions of the Sonoran Desert Toad (Incilius alvarius). Preliminary evidence suggests that 5-MeO-DMT with concurrent psychological support has the potential to alleviate TRD severity. This research seeks to further explore the potential therapeutic benefit.

The purpose of this study is to investigate the safety and efficacy of intranasal 5-MeO-DMT in combination with psychological support in participants 18 years to 75 years of age with treatment-resistant depression.

The study involves the following in-person activities between a 8-16 week period:

• Screening period
• Three (3) psychedelic preparation visits
• Drug administration session
• Three (3) psychedelic integration visits
• Three (3) follow-up visits
• The study will also include blood draws and laboratory tests, ECGs, clinical and psychiatric evaluations and the completion of patient reported outcome questionnaires

• The study’s procedures and therapy are at no cost to the participant.
• Eligible participants will be randomized in a 1:1:1 ratio to receive a single dose of either a low, medium, or high dosage. This study is “quadruple-masked” meaning that no participants, research staff, therapists, or investigator(s) will know which dosage you receive.
• 5-MeO-DMT will be administered in a safe setting with continual support from trained and experienced therapists. The support includes careful preparation before the experience and processing after the experience. Psychedelic effects are typically temporary, and safety is continually monitored.

• Eligible participants will taper off of, and discontinue from, all antidepressants as part of their participation in the study. This plan is created with study physician approval and participant safety is monitored. Participants MUST NOT discontinue ANY medication without the physician’s approval. If necessary, the study physician will consult with patients’ providers.
• Participants should not be pregnant, nursing or planning a pregnancy, and must agree to use a highly effective method of birth control during the entire course of the clinical trial.
• Risks to participation will be reviewed extensively during the screening period and throughout the entirety of the trial.
• All visits take place in person at The Bill Richards Center for Healing, Aquilino Cancer Center, 9905 Medical Center Drive, Rockville, MD.