Table 1.
Screening | Inclusion (day 0) | Week 1 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 25 | Week 26 | |
Introduction, informed consent, screening | X | |||||||||
Height | X | X | X | |||||||
Hip and waist circumference | X | X | X | X | X | |||||
Body weight | X | X | X | X | X | X | ||||
Blood pressure and heart rate | X | X | X | X | X | X | ||||
Clinical evaluation of suicide risk | X | X | X | X | X | X | ||||
Standard blood sampling and safety markers | X | X | X | X | ||||||
Fasting blood and urine samples | X | X | ||||||||
The Schizophrenia Quality of Life Scale | X | X | ||||||||
Clinical Global Impression Severity | X | X | ||||||||
Global Assessment of Psychosocial Disability | X | X | ||||||||
Alcohol Use Disorders Identification Test | X | X | ||||||||
Drug Use Disorders Identification Test | X | X | ||||||||
Fagerström Test for Nicotine Dependence | X | X | ||||||||
Clicker test | X | X | ||||||||
Positive and Negative Syndrome Scale | X | X | ||||||||
DXA scanning | X | X | ||||||||
Activity device distributed | X | X | ||||||||
Activity device collected | X | X | ||||||||
Drug dispensing/returned | X | X | X | X | X | X | ||||
Adherence/practice study treatment self-administration | X | X | X | X | X | X | X | X | X | |
Adverse event assessment | X | X | X | X | X | X | X | X | X | |
Follow-up by phone call | X | X |
DXA scan will be performed at baseline and at the termination of study participation. Activity measurements will be collected continuously during the first (week 1) and last week of participation (week 26) by using a wearable activity device91–93 (table 1). At baseline and the last visit, potential effects on the reward value of a sweet–fat stimulus will be examined using a progressive ratio task ‘clicker test’,94 a Positive and Negative Syndrome Scale–Six Items interview95 will be performed, and fasting blood and urine samples will be collected (box 3).
DXA, dual-energy X-ray absorption.