Pilot study of a CCKB antagonist in patients with panic disorder: preliminary findings

L-365,260 is a CCKB antagonist which has been shown to completely prevent CCK-4-induced symptoms of panic attack in single-dose (50 mg) placebo-controlled studies in patients with panic disorder. The present report is data from one site (n = 38) in a multicenter study (n = 88) designed 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 between 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 measures, including the frequency of panic attacks, the Physician's Global Improvement Scale, and the Hamilton Rating Scale for Anxiety, were significantly improved over baseline values. L-365,260 was well-tolerated; the most common drug-related adverse events were headache and lightheadedness. Further testing of L-365,260 at higher dosages, or testing of other CCKB antagonists, is required to rule out the usefulness of this novel treatment approach.