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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).