L-365,260 is a CCKB antagonist which has been shown to contpletely pre
vent CCK-4-induced symptoms of panic attack in single-dose (50 mg) pla
cebo-controlled studies in patients with panic disorder. The present r
eport is data from one site (n = 38) in a multicenter study (n = 88) d
esigned to assess the preliminary efficacy and safety of L-365,260 in
patients meeting DSM-III-R criteria for panic disorder with or without
agoraphobia. In order to participate, male and female patients were b
etween 18-55 years of age and in good physical health. Following a one
-week single-blind placebo lead-in, patients were randomized to 30 mg
four times daily of L-365,260 (n = 18; 7 M, 11 F) or placebo (n = 20;
9 M, 11 F) for six weeks. At end of study, none of the efficacy measur
es, including the frequency of panic attacks, the Physician's Global I
mprovement Scale, and the Hamilton Rating Scale for Anxiety, were sign
ificantly improved over baseline values. L-365,260 was well-tolerated;
the most common drug-related adverse events were headache and lighthe
adedness. Further testing of L-365,260 at higher dosages, or testing o
f other CCKB antagonists, is required to rule out the usefulness of th
is novel treatment approach. (C) 1995 Wiley-Liss, Inc.