Lu AA21004 and paroxetine: comparison of effects on sleep; version 1

• Research type

  Research Study

• Full title

  Randomised, double blind, four-way crossover, placebo controlled, active comparator, polysomnographic study investigating the effects of Lu AA21004 in healthy young men (11-009)

• IRAS ID

  84887

• Contact name

  Malcolm Boyce

• Sponsor organisation

  H. Lundbeck A/S

• Eudract number

  2011-000427-33

• Research summary

  Lu AA21004 is a new experimental medicine for treating depression and anxiety. Medicines for depression and anxiety, such as paroxetine (Seroxat) have many side effects, including reducing the quality of sleep in some people. We hope that Lu AA21004 will work better and have fewer side effects than existing medicines. We??re doing this study to compare the effects of Lu AA21004 and paroxetine on sleep. We'll also take blood samples for ??biomarker?? research, to study substances that may be linked to depression and anxiety or to the way the body handles and responds to the study medicine. Biomarker research will include tests on DNA (pieces of genes).24 healthy men aged 18??35 years will take part. They??ll have 4 treatment sessions, separated by at least 21 days. In each session, they??ll take 3 daily doses of one of the following treatments:* 20 mg Lu AA21004* 40 mg Lu AA21004* 20 mg paroxetine* Placebo Participants will take all 4 treatments during the study. A computer will decide in which order participants take the treatments.We'll do polysomnography (PSG) while the participants are asleep. PSG is a painless test that measures electrical activity of the brain, heart rate and rhythm, and breathing. Participants will make 2 outpatient visits and have 4 inpatient stays lasting 5 nights each (20 nights in total). Volunteers will participate in the study for no longer than 16 weeks from beginning to end.The study will take place at one 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

  Scotland A REC

• REC reference

  11/IE/0142

• Date of REC Opinion

  29 Sep 2011

• REC opinion

  Further Information Favourable Opinion