Table 1.
Week of treatment | Baseline | 1 | 2 | 4 | 6 | 8 | 10 | 12 | 14 | 16 |
---|---|---|---|---|---|---|---|---|---|---|
Physical exam, EKG, demographic information and forms |
X |
|
|
|
|
|
|
|
|
|
Childhood Experience of Care and Abuse Questionnaire (CECA.Q), and Ways of Coping Checklist (WCC) |
X |
|
|
|
|
|
|
|
|
|
Drug Use Information |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
Tobacco Craving Questionnaire, smoking questionnaire, Nicotine Dependency Form and CO (smokers only, 30 minutes post cig) |
X |
|
|
|
|
X |
|
|
|
X |
Fertility and Sexual Behavior Questionnaire , menstrual attitude scale |
X |
|
|
|
|
|
|
|
|
X |
Urine pregnancy test |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
Vital signs, blood pressure, weight, waist circumference |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
Prolactin |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
Estradiol, progesterone* |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
Salivary cortisol |
X |
|
|
|
|
X |
|
|
|
X |
Risperidone and 9-OHrisperidone plasma levels, thyroid panel including TRH |
X |
|
|
|
|
X |
|
|
|
X |
CBC, Chemistry and full lipid panel (Total cholesterol, triyglycerides, HDL, LDL, VLDL), FBG, HbA1C |
X |
|
|
|
|
X |
|
|
|
X |
Highly sensitivity C- reactive protein (CRP) |
X |
|
|
|
|
X |
|
|
|
X |
Osteocalcin, bone specific alkaline phosphatase, urinary NTx and serum CTx |
X |
|
|
X |
|
X |
|
|
|
X |
Cytokines |
X |
|
|
|
|
X |
|
|
|
X |
Parathyroid hormone, homocysteine, and 25-hydroxyvitamin D levels |
X |
|
|
|
|
X |
|
|
|
X |
Medication accountability and pill count |
|
X |
X |
X |
X |
X |
X |
X |
X |
X |
BPRS, SANS, CDS. CGI |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
RBANS |
X |
|
|
|
|
|
|
|
|
X |
SAS, BAS, SEC |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
AIMS |
X |
|
|
|
|
|
|
|
|
X |
SF-36, DAI, FSFI, FSDS-R, ASEX, PGWB |
X |
|
|
X |
|
X |
|
X |
|
X |
Menstrual diary** (kept daily) checked |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
Breast examination*** |
X |
|
X |
X |
X |
X |
X |
X |
X |
X |
Exit Interview, Perceived Study Benefits | X |
*Subjects will be given a salivary test at each visit and will be asked to perform one for the next week, refrigerate and return.
**Phone calls will be made twice weekly to remind the subjects to keep their menstrual diary daily.
***Done by female research staff or nurse (will only be repeated if galactorrhea is noted during baseline).