Table 2.
Time and events – study procedures [informed by (35)].
| Time and events – study procedures | Screening period (2 to 6 weeks) |
Preparatory period w/enrollment confirmation (2 to 11 weeks) |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Screening | Enrollment | Preparatory | Baseline MADRS T1 | Baseline & enrollment confirmation | ||||||
| Visit | Phone screening | Screening | V0 | V1 | V2 | V3 | V4 | |||
| Visit description | Phone calls | In-person visits & labs | Enrollment | Prep 1 | Prep 2 | MADRS T1 assessment at site | Prep 3 & enrollment confirmation | |||
| Initial phone screen | ✓ | |||||||||
| Informed consent | Send Copy | ✓ | ||||||||
| Follow-up phone screen | ✓ | |||||||||
| Assess eligibility | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| Medical/psychiatric history | ✓A | ✓ | ✓ | ✓ | ✓ | |||||
| Past/current medication & adherence | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| Weight, resting vitals | ✓ | |||||||||
| Physical exam | ✓ | |||||||||
| ECG & rhythm stripH | ✓ | |||||||||
| Clinical lab tests | ✓ | |||||||||
| Drug screen | ✓ | ✓ | ||||||||
| Pregnancy screen | ✓ | ✓ | ||||||||
| Enter participant in eCRF | ✓ | |||||||||
| Record | ✓ | ✓ | ✓ | ✓ | ||||||
| Medication taper | ✓ | ✓ | ✓ | |||||||
| Study enrollment | ✓ | ✓ Confirmed | ||||||||
| All AEsB | ✓ | ✓ | ✓ | ✓ | ||||||
| 90-min preparatory session | ✓ | ✓ | ✓ | |||||||
| Phone call follow-upC | ✓ | |||||||||
| Time and events – study procedures (continued) | Treatment period ~8 weeks (+/-3 weeks) |
Follow-up period & study termination (~4 weeks) 13 weeks (+/-3 weeks) post baseline |
||||||||
| Treatment 1 | Treatment 2 | Outcome | Study Termination | |||||||
| Visit | V5 | V6 | V7 | V8 | V9 | V10 | V11 | V12 | V13 | V14 |
| Visit description | Exp. 1 | Int 1.1 | Int. 1.2 | Int 1.3 | Exp. 2 | Int. 2.1 | Int 2.2 | Int 2.3 | MADRS T2 assessment at site | Study termination |
| Past/current medication and adherence | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Drug screen | ✓ | ✓ | ||||||||
| Pregnancy screen | ✓ | ✓ | ||||||||
| Record | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| All AEsD | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Administer IP | ✓ | ✓ | ||||||||
| 8-hour Exp. Session | ✓ | ✓ | ||||||||
| BP, Pulse, TemperatureE | ✓ | ✓ | ✓F | |||||||
| Overnight Stay | ✓ | ✓ | ||||||||
| 90-min Integrative Session | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| Phone Call Follow-upG | ✓ | ✓ | ||||||||
| Weight | ✓ | |||||||||
AAt Screening, collect data on previous hospitalizations, healthcare utilization and economic productivity. Request participants to obtain medical/psychiatric records to bring to the in-person screening.
BAll Adverse Events (AEs) includes collecting Serious Adverse Events, AEs of Special Interest, AEs of Psychiatric Status, AEs requiring medical advice or attention, AEs that indicate withdrawal of a participant, and all other AEs.
CIf needed, call participant to confirm medication tapering and stabilization is complete prior to Visit 3.
DAll Adverse Events (AEs) includes collecting Serious Adverse Events, AEs of Special Interest, AEs of Psychiatric Status, AEs requiring medical advice or attention, AEs that indicate withdrawal of a participant, and all other AEs.
EDuring Dosing Sessions, vitals are measured before Investigational Product administration, immediately before the supplemental dose is administered (or would be, if supplemental dose not given), and approximately 8 h after initial dose, and as needed.
FAt Study Termination, only blood pressure needs to be measured.
G4 days of phone call follow-up: Day 2 and 7 after the Dosing Session, with two additional calls in between.
HWe do not repeat the ECGT during the MDMA dosing sessions, since we will avoid possible interference with the therapy facilitated by MDMA.