matched placebo for aripiprazole 15mg/day

This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.

Cross-over Aripiprazole and Placebo

Sex: Female, Male

Region of Enrollment

Evaluating change in weight (lbs) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.

Aripiprazole

Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.

Placebo

Change From Baseline in Weight (Lbs)

Evaluating change in Body Mass Index (BMI) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

Change From Baseline in Body Mass Index (BMI)

Evaluating change in waist-hip ratio (WHR) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

Change From Baseline in Waist-hip Ratio (WHR)

Evaluating change in fasting total cholesterol between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

Change From Baseline in Fasting Total Cholesterol

Evaluating change in low-density lipoprotein (LDL) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

Change From Baseline in Low-density Lipoprotein (LDL)

Evaluating change in high-density lipoprotein cholesterol (HDL-C) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)

Evaluating change in triglyceride levels between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

opc/умор

A Placebo-Controlled, Cross-Over Trial of Aripiprazole

Xyrem for Treatment Refractory Insomnia Due to PTSD

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