Table 2.
Assessment schedule (time in weeks)
| B | Stabilization | O | Maintenance | ||||||
|---|---|---|---|---|---|---|---|---|---|
| -1 | 0 | 4 | 8 | 12 | 14 | 16 | Q 2 wks × 8 wks then monthly visits | Cross over to Valproic Acid for mood episode on lithium | |
| CGI-S-BP by doctor | X | X | X | X | X | X | X | X | X |
| Mood episode checklist | X | X | X | X | X | X | X | X | X |
| Consent | X | ||||||||
| MINI- PLUS | X | ||||||||
| Demographics/course of illness | X | ||||||||
| HAM-A | X | X | X | X | |||||
| MADRS | X | X | X | X | X | X | |||
| QIDS-SR 16 | X | X | X | X | X | X | X | X | X |
| YMRS/CARS – M | X | X | X | X | X | ||||
| Side Effects Survey | X | X | X | X | X | X | X | X | X |
| Q-LES-Q | X | X | X | X | |||||
| IRS | X | X | X | X | |||||
| MSSI | X | X | X | X | X | X | |||
| Serious Adverse Event Form | X | X | X | X | X | X | X | X | |
O observation phase, B baseline, ET Early Termination, Mini-PLUS Extended Mini-International Neuropsychiatric Interview, MADRS Montgomery Asberg Depression Rating Scale, QIDS-SR 16 Quick Inventory of Depressive Symptomatology Self-Report, YMRS Young Mania Rating Scale, CARS-M: Clinician Administered Rating Scale for Mania, HAM-A Hamilton Anxiety Rating Scale, CGI-BP Clinical Global Impressions of Severity - Bipolar Version, Q-LES-Q quality of life, enjoyment, and satisfaction questionnaire, IRS impulsivity rating scale, MSSI The Modified Scale of Suicidal Ideation