Table 1. Study timeline and measurements.
| Visit | 1 Baseline/screening* | 2 Interim assessment | 3 Interim assessment | 4 Interim assessment | 5 Interim assessment | 6 Interim assessment | 7 Primary endpoint | 8 Post-discontinuation follow-up |
|---|---|---|---|---|---|---|---|---|
| Week | 0 | 4 | 8 | 12 | 16 | 20 | 24 | 28 |
| Screening and consent | ||||||||
| Informed consent | x | |||||||
| Inclusion/exclusion criteria | x | |||||||
| Demographics | x | |||||||
| Medical history | x | |||||||
| Psychiatric and family history | x | |||||||
| Concomitant medication | x | x | x | x | x | x | x | x |
| Pregnancy test (females only)† | x | |||||||
| SCID-5-RV | x | |||||||
| Safety | ||||||||
| Adverse events | x | x | x | x | x | x | x | x |
| Efficacy | ||||||||
| MADRS | x | x | x | x | x | x | x | x |
| BDRS | x | x | x | x | x | x | x | x |
| YMRS | x | x | x | x | x | x | x | x |
| HAM-A | x | x | x | x | x | x | x | x |
| CGI-BP-S | x | x | x | x | x | x | x | x |
| CGI-BP-I | x | x | x | x | x | x | x | |
| PGI | x | x | x | x | x | x | x | |
| Functioning and quality of life | ||||||||
| Q-LES-Q | x | x | x | x | x | x | x | x |
| SOFAS | x | x | x | x | x | x | x | x |
| LIFE-RIFT | x | x | x | x | x | x | x | x |
| Health economics | ||||||||
| AQOL-4D | x | x | x | |||||
| RUQ | x | x | x | |||||
| Exploration of biological correlates | ||||||||
| Blood sampling | x | x | ||||||
| Other moderator variables | ||||||||
| SAPAS | x | |||||||
| DQES version 2 | x | |||||||
| Cognition | ||||||||
| Digit span backwards task | x | x | ||||||
| Digit span forwards task | x | x | ||||||
| Trail making task | x | x | ||||||
| Symbol Digit Task | x | x | ||||||
| Other | ||||||||
| Drug dispensation | x | x | x | x | x | x |
AQOL-4D = Assessment of Quality of Life Instrument 4D; BDRS = Bipolar Depression Rating Scale; CGI-BP-S = Clinical Global Improvement for Bipolar Disorder – Severity; CGI-BP-I = Clinical Global Improvement for Bipolar Disorder – Improvement; DQES = Dietary Questionnaire for Epidemiological Studies; HAM-A = Hamilton Anxiety Rating Scale; LIFE-RIFT = Longitudinal Interval Follow-Up Evaluation – Range of Impairment Functioning Tool; MADRS = Montgomery-Åsberg Depression Rating Scale; PGI = Patient Global Impression; Q-LES-Q = Quality of Life Enjoyment and Satisfaction Questionnaire; RUQ = Resource Use Questionnaire; SAPAS = Standard Assessment of Personality – Abbreviated Scale; SOFAS = Social and Occupational Functional Assessment Scale; YMRS = Young Mania Rating Scale.
Baseline and screening interviews may be split to accommodate participant time.
If participant is not sexually active or the treating clinician feels it is not warranted, this is not compulsory.