Table 2.
Observations and tests
| Eligibility assessment | Protocol treatment | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Week |
-4 to 0 |
0 |
* |
8 |
12 |
26 |
52 |
78 |
104 |
| Doctor’s check |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
| Height†, body weight |
○ |
|
|
|
|
○ |
○ |
○ |
○ |
| Blood test‡ |
○ |
○ |
|
○ |
○ |
|
○ |
|
○ |
| PANSS§ |
|
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
| CGI-SS |
○ |
|
○ |
○ |
○ |
○ |
○ |
○ |
○ |
| CGI-S |
|
○ |
○ |
|
|
|
|
|
|
| CGI-I |
|
|
|
○ |
○ |
○ |
○ |
○ |
○ |
| MacCAT-CR|| (if possible) |
|
○ |
|
|
|
|
|
|
|
| Social activity (PSP, EQ-5D) |
|
○ |
○ |
|
|
○ |
○ |
|
○ |
| DIEPSS |
|
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
| Adverse events | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ||
PANSS, Positive and Negative Syndrome Scale; CGI-SS, Clinical Global Impression-Suicide Scale; CGI-S, Clinical Global Impression-Severity; CGI-I, Clinical Global Impression-Improvement; MacCAT-CR, MacArthur Competence Assessment Tool for Clinical Research; PSP, Personal and Social Performance Scale; EQ-5D, Euro Quality of life-5 dimension; DIEPSS, Drug-Induced Extrapyramidal Symptoms Scale.
In case of study discontinuation, all observations and tests except for MacCAT-CR will be performed.
* At the time of start of single-drug therapy.
† Measured only at the time of eligibility assessment.
‡Cr (serum creatinine), HbA1c (glycohemoglobin A1c),WBC, RBC, hemoglobin, hematocrit, platelet count, AST (aspartate aminotransferase), ALT (alanine aminotransferase), CK (creatine kinase), blood glucose, prolactin.
§ Remission is evaluated in accordance with the Andreasen definition (rating below mild on all 8 items of the PANSS for 6 consecutive months or more).
|| Assessed at the latest by Week 12.