An open-label, single-arm and multi-center study for 16 weeks
An open-label, single-arm and multi-center study for 16 weeks, to study the improvement of weight gain in patients with schizophrenia who switched from olanzapine to lurasidone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Lurasidone was oral administrated with a meal or within 30 min after eating in the evening. The maintenance dose of olanzapine from Day 0 to Day 6, than tapered until discontinuation from Day 7 to Day 27. Lurasidone initiated with 40mg/d on Day 0, maintained until Day 13, with a flexible dose (40-80mg/d, qd) from Day 28 to Day 111.
Beijing Anding Hospital
Beijing, Beijing Municipality, China
Mean weight change
Changes in body weight at the end of treatment compared to baseline
Time frame: from baseline to week 16
Change in Positive and Negative Syndrome Scale (PANSS) scores
Change in PANSS scores at the end of treatment compared to baseline.
Time frame: from baseline to week 16
Change in the Clinical Global Impressions-Severity (CGI-S) scores
Change in CGI-S scores at the end of treatment compared to baseline.
Time frame: from baseline to week 16
Change in 12-Item Short Form Survey (SF-12) scores
Change in SF-12 scores at the end of treatment compared to baseline
Time frame: from baseline to week 16
Change in waist circumference
Change in waist circumference at the end of treatment compared to baseline. Wrap the tape around 0.5 to 1.0 cm above the belly button, and measure the circumference.Obese patients wrap a tape measure around the widest part of their waist.
Time frame: from baseline to week 16
Change in the serum prolactin (PRL)
Change in PRL at the end of treatment compared to baseline.
Time frame: from baseline to week 16
Change in Calgary Depression Scale for Schizophrenia (CDSS) scores
Change in CDSS scores at the end of treatment compared to baseline.
Time frame: from baseline to week 16
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Change in fasting lipids
Change in fasting lipids(total cholesterol, triglycerides, high density liptein cholesterol, low density lipoprotein, Non-high density liptein cholesterol) at the end of treatment compared to baseline.
Time frame: from baseline to week 16
Change in fasting plasma glucose
Change in fasting plasma glucose at the end of treatment compared to baseline.
Time frame: from baseline to week 16
Change in hemoglobin A1c (HbA1c)
Change in HbA1c at the end of treatment compared to baseline.
Time frame: from baseline to week 16
Change in the Epworth Sleepiness Scale
Change in the Epworth sleepiness scale at the end of treatment compared to baseline. A score of 10 or greater raises concern.
Time frame: from baseline to week 16