Table 3.

Research process sheet

Study duration (weeks)	0	4±1	8±1	13±1	26±1	52±2	78±2	104±2	130±2	156±2
Visit	1	2	3	4	5	6	7	8	9	10
Informed consent	×
Collect basic medical history
Diagnosed according to DSM-IV diagnostic criteria	×
Check the group/exclusion criteria	×
Collect demographics*	×
Medical history, treatment history, family history	×
Social support	×	×	×	×	×	×	×	×	×	×
Smoking and drinking	×	×	×	×	×	×	×	×	×	×
Antipsychotic use	×	×	×	×	×	×	×	×	×	×
MECT and psychotherapy	×	×	×	×	×	×	×	×	×	×
Concomitant disease and symptoms	×	×	×	×	×	×	×	×	×	×
Drug combination	×	×	×	×	×	×	×	×	×	×
Safety evaluation
Physical examination†	×
Vital sign examination‡, abdominal circumference	×	x	x	×	×	×	×	×	×	×
Routine blood test	×	x	x	×	×	×	×	×	×	×
Blood biochemistry§	×	x	x	×	×	×	×	×	×	×
Other¶	×	x	x	×	×	×	×	×	×	×
Pregnancy test (if necessary)	×	x	x	×	×	×	×	×	×	×
12-lead ECG	×	x	x	×	×	×	×	×	×	×
Record adverse events	×	x	x	×	×	×	×	×	×	×
EPS (SAS/BARS/AIMS)	×	x	x	×	×	×	×	×	×	×
Sexual function evaluation (ASEX)	×	x	x	×	×	×	×	×	×	×
Subjective perception of medication (MSQ/DAI/SWN)	×	x	x	×	×	×	×	×	×	×
Therapeutic evaluation
PANSS, CDSS	×	x	x	×	×	×	×	×	×	×
CGI-S	×	x	x	×	×	×	×	×	×	×
Functional assessment (PSP/SF-36)	×	x	x	×	×	×	×	×	×	×
Relapse/readmission	×	x	x	×	×	×	×	×	×	×
Other works
End sheet††										×
Ask whether to enter an extended long-term follow-up study‡‡										×

* Demographic data: age, gender, ethnicity, height, weight, occupation, marriage and economic income.

† Physical examination: skin, lymph node, facial features, head and neck (including thyroid), heart, lung, abdomen, limbs, external genitalia, motor system and nervous system.

‡ Vital signs check: temperature, pulse, breathing and blood pressure.

§ Blood biochemistry: liver function (alanine aminotransferase (ALT), aspartate aminotransferase (AST)), kidney function (urea nitrogen (BUN), inosine (Cr)), fasting blood glucose and glycated haemoglobin.

¶ Other: prolactin and thyroxine.

†† Ending records should be completed when the study is terminated early. The follow-up time window should be ±1 week for less than 52 weeks and ±2 weeks for more than 52 weeks.

‡‡ Including subjects who prematurely discontinued the study. Among them, 4 weeks and 8 weeks of follow-up are suitable for patients with acute exacerbation or fluctuating conditions.

This symbol “x”signifies completion of the visit.

AIMS, Abnormal Involuntary Movement Scale; ASEX, Arizona Sexual Experience Scale; BARS, Barnes Akathisia Rating Scale; CDSS, Calgary Depression Scale for Schizophrenia; DAI, Drug Attitude Inventory; MSQ, Medication Satisfaction Questionnaire; PANSS, Positive and Negative Syndrome Scale; PSP, Personal and Social Performance Scale; SAS, Simpson-Angus Scale; SF-36, Short Form-36; SWN, Subjective Well-Being Under Neuroleptics Scale.