Antidepressant Effects of NR2B in Major Depression
Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
Summary
Purpose : This study will determine whether MK-0657, a selective NR2B Antagonist, can quickly
improve symptoms of depressed mood, psychomotor retardation, poor motivation and reduced
enjoyment of things in patients with major depression.
MK-0657 decreases the activity of a brain receptor called NMDA, which the chemical glutamate
binds to, possibly inducing a rapid antidepressant response. People between 18 and 55 years
of age who have major depression of at least 4 weeks' duration and have not been helped by
two antidepressants approved for major depression may be eligible for this study. Women who
are able to have children are excluded. Participants are admitted to the NIH Clinical Center
for two study phases, as follows. Phase I (1 to 2 weeks): Patients are tapered off their
current medications. Phase II (7 weeks): Patients are randomly assigned to take either
MK-0657 or placebo (look-alike capsules with no active ingredient) by mouth for 12 days. At
some point during the second part this phase, patients who had been taking MK-0657 are
switched over to placebo and those who had been taking placebo are switched to MK-0657.
Participants undergo the following procedures during the study:Physical examination twice (at
the beginning and at the end of the study) Electrocardiogram (ECG) four times Blood tests
about six times Rating scales up to 28 times to assess the effects of MK-0657 on mood and
thinking Blood pressure measurements three times a day.
Study examines the effectiveness of a new medication, targeting a system called glutamate,
will improve depression when compared with placebo.