Randomised, duoble-blind, placebo-controlled, 3-way crossover study to investigate the effect of 10 mg Lu AA21004 and 30 mg mirtazapine on actual driving performance, psychomotor function and cognitive function in healthy subjects

Depression is a widespread disease which also results in a widespread use of
antidepressants. It is well known that these drugs, that cross the blood-brain
barrier, can cause sedation which then can have a negative influence on daily
functioning of patients. This is of special importance for patients who drive a
car and for whom a drop in their alertness can be of a danger to themselves and
to others.
Because there is a great potential risk of non-compliance when patients are
obliged to refrain from driving a car it is of great importance to investigate
the actual influence of these drugs on driving performance. This with the
purpose to inform patients well about the potential risks.
Lu AA21004 is new drug in development for the treatment of depression. The
purpose of this study is to gather more information about the sedative effects
of 10 mg Lu AA21004 after 1 dosing and to investigate the effects after
multiple dosing (15).

The objective of the current study is to investigate the possible effects on
driving ability of a new anti-depressant (10 mg Lu AA21004) after 1 day of
dosing and after 15 days of dosing. These effects will be compared to those of
mirtazapine (30 mg) and placebo.

Randomised, double-blind, placebo-controled, 3-way crossover study.
- 21 volunteers, age between 21 and 45, will be randomly assigned to 1 of the
treatment orders.
- The study consists of 3 treatment periods each lasting 16 days. On days 1
till 15 the volunteer takes the medication. On day 2 and 16 of each period the
driving ability, psychomotor functions and cognitive functions will be tested.
Between each treatment period will be a wash-out period of at least 14 days.
- Before participation subjects are medically screened and all the tests used
in the study are practiced.
- On each testday the computertests are conducted 12 hours after dosing. The
driving test is conducted 13,5 hours after dosing.

The studied treatments consist of multiple dosing (1 dosing per day for 15
consecutive days) of 10 mg Lu AA21004, 30 mg mirtazapine and placebo.
Administration of the medication is double-blind. Between each treatment period
will be a wash-out period of at least 14 days.

The total amount of time invested in the study by each subject will be
approximately 41 hours. Before final participation a medical screening will
take place, during which, besides a physical check-up, an urinesample and a
bloodsample (12 ml) will be collected. Also an ECG will be made. Before start
of the treatment periods 2 training sessions are planned during which all the
used tests are practiced. Each subject comes to the university on day 1 of each
treatment period to collect the medication for that period. Female subjects
will be tested for pregnancy. For this purpose a bloodsample (8 ml) will be
taken. This test is repeated on day 16 of each period. The subject takes the
medication in the evening at home during each testperiod for 15 days and comes
during each period to the university on days 2 and 16 to be tested. Each of
these visits will last 4 hours. On each testday a bloodsample (8 ml) will be
taken to determine the amount of study medication present in the body. The
night before a testday subjects have to make sure they sleep well. Alcohol-,
and caffeine intake are limited during participation. Besides the fact that it
is possible that side effects will occur and that subjects are advised not to
drive a car on their on own during testperiods (until at least 48 hours after
last dosing) there are no considerable risks involved in participation.