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Table 1 Schedule of events for study procedures

From: Treating symptomatic hyperprolactinemia in women with schizophrenia: presentation of the ongoing DAAMSEL clinical trial (Dopamine partial Agonist, Aripiprazole, for the Management of Symptomatic ELevated prolactin)

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
  1. *Subjects will be given a salivary test at each visit and will be asked to perform one for the next week, refrigerate and return.
  2. **Phone calls will be made twice weekly to remind the subjects to keep their menstrual diary daily.
  3. ***Done by female research staff or nurse (will only be repeated if galactorrhea is noted during baseline).