Comparison of 20 mg vortioxetine tablet and capsules;version 1
Research type
Research Study
Full title
Interventional, randomised, double-blind 4-way crossover study comparing the gastro-intestinal tolerability and absorption profile of vortioxetine after administration of modified-release formulations in healthy women.
IRAS ID
149543
Contact name
Adeep Puri
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2014-000121-20
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
Research summary
Vortioxetine (also known as Brintellix® or Lu AA21004), is a new medicine that can be prescribed by doctors for treatment of depression
We’re doing this study to compare 4 different forms of vortioxetine: a tablet form and three new capsule forms. We want to compare side effects related to symptoms in the gastro- intestinal tract after intake of the tablet and capsule forms, and find out if they give similar blood levels of vortioxetine. We’ll also take blood samples for ‘biomarker’ research, to study substances that may be linked to depression or to the way the body handles and responds to the vortioxetine. The biomarker research will include tests on genes (pieces of DNA).
The most common side effect of vortioxetine is nausea, which occurs more often in women than in men. We’re doing this study in healthy women only, to find out if one of the new capsule forms causes less nausea than the tablet form.
Up to 40 healthy women, aged 18–45 years, will take part. They’ll have 4 study sessions, and take a single dose of 20 mg vortioxetine in each session. They’ll take a different tablet or capsule form in each session – a computer will decide the order in which participants take the treatments. All the treatments will look the same, so neither we nor the participant will know which one they’re taking.
Participants will take up to 15 weeks to finish the study: they’ll make 1 outpatient visit and have 4 inpatient stays (16 nights in total).The study will take place at 1 centre in London. We’ll recruit participants by advertising (newspaper, radio, and websites), word of mouth, from volunteer databases, and our website.
A pharmaceutical company, H. Lundbeck A/S, is funding the study.
REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/0244
Date of REC Opinion
1 Apr 2014
REC opinion
Further Information Favourable Opinion