Dyslipidemia Clinical Trial
Official title:
Reversal of Antipsychotic-Induced Hyperprolactinemia, Weight Gain, Hyperglycemia and Dyslipidemia by Aripiprazole Add-on Therapy in the Treatment of Schizophrenia and Bipolar Disorder: An Open-Label Trial
This is a prospective, open-label study to evaluate the efficacy and safety in reducing antipsychotic-induced hyperprolactinemia, weight gain, and dyslipidemia by aripiprazole. Approximate 60 patients will be recruited to achieve at least 40 evaluable patients.
A.Screening / Baseline visit (V1; Day 0) After signing the informed consent form, patients'
DSM-IV multiaxial examination, physical examination, vital sign, pregnancy test, BMI will be
conducted. The demographics, medical history, and concomitant medication will be recorded.
After evaluating all variables obtained, the eligible patients will be enrolled into
study.Patients who fulfill the inclusion / exclusion criteria will be performed the
laboratory tests, PANSS, EPS (AIMS & BARS), menstrual function, sexual function (Arizona
sexual experience scale) and prolaction. Afterwards, the treatment period will be started to
add-on with first medication (7.5 or 15 mg daily by patient, which was prescribed by
investigator) to current antipsychotics at this visit. Besides, drug accounting and adverse
events will also be recorded at this visit. Patients are maintained on current doses of
antipsychotics, and all other medicines.
B.Treatment phase (V2~V3; 2~4 Week finished; 14±3~28±3 Day finished) The vital sign,
physical examination, BMI, laboratory tests (at V3), PANSS, EPS (AIMS & BARS), menstrual
function, sexual function (Arizona sexual experience scale), and prolactin will be carried
out. Concomitant medication, adverse events, and drug accounting will also be recorded at
this visit. Study drug could be titrated with a flexible dose from 7.5 to 30 mg QD. All dose
adjustments should be made with the approval of the investigator.
C.Completion visit (V4; 8 Week Finished; 56±7 Day finished, or Early termination) The vital
sign, physical examination, pregnancy test, BMI, laboratory tests, PANSS, EPS (AIMS & BARS),
menstrual function, sexual function (Arizona sexual experience scale), prolactin will be
carried out. Concomitant medication, adverse events, and drug accounting will also be
recorded at this visit.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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