Table 2.
Measures & schedule of events.
| Scale |
Screen/Washout |
Intake |
Study Infusion |
Follow Up |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Day | −21 to −1 | 0 | 1 | 2 | 3 | 4 | 7b | 14 | 21 | 28 |
| MADRS | x | x | x | x | x | x | x | x | x | x |
| QIDS-SR | x | x | x | x | x | x | x | x | x | x |
| MMSE | x | |||||||||
| MCCB | x | x | x | |||||||
| PROMIS | x | x | x | x | x | x | ||||
| CADSSa | x | x | x | x | x | x | x | x | x | |
| CGI | x | x | x | x | x | x | x | x | x | x |
| QLESQ | x | x | x | x | x | x | ||||
| CSSRS | x | x | x | x | x | x | x | x | x | x |
| BPRSa | x | x | x | x | x | x | x | x | x | |
| PRISE | x | x | x | x | x | x | x | x | x | x |
| EEG | x | x | x | x | ||||||
MADRS Montgomery-Asberg Depression Rating Scale.
MMSE Mini Mental Status Exam.
MCCB MATRICS Consensus Cognitive Battery.
PROMIS Patient Reported Outcomes Measurement Information System- Emotional Distress-Anxiety Short Form.
CADSS Clinician Administered Dissociation Symptom Scale.
CGI Clinician Global Improvement.
QLESQ Quality of Life Enjoyment and Satisfaction Questionnaire.
CSSRS Columbia-Suicide Severity Rating Scale.
PRISE Patient Reported Inventory of Side Effects.
QIDS-SR Quick Inventory of Depressive Symptomatology –Self Report.
CADSS and BPRS administered at 0, 40, 120, and 240 min on infusion days.
Day 7 follow up assessment is the primary efficacy rating for the study. Responders at day 7 continue weekly follow up assessments through day 28 to monitor treatment response and relapse. Non-responders at day 7 are exited from study.