Conditions: Panic Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 46
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effectiveness of Org 25935 vs. placebo given in combination with cognitive-behavioral therapy (CBT) to reduce the symptoms of panic disorder. It is hypothesized that treatment with Org 25935 at a dose of 4 mg or 12 mg will differ significantly from placebo with respect to the Panic Disorder Severity Scale (PDSS) total score over 3 weeks of therapy.

Detailed description:

Arms:
arm 1: Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period. arm 2: Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period. arm 3: Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.

Interventions: intervention 1: Cognitive-behavioral therapy intervention 2: Org 25935 intervention 3: Org 25935 intervention 4: Placebo
Intervention descriptions: intervention 1: Participants underwent 5 weekly CBT session (sessions were 60-90 minutes in duration). intervention 2: 4 mg Org 25935 is given in tablet form, a single dose 2 hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a 2-week period. intervention 3: 12 mg Org 25935 is given in tablet form, a single dose two hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a two-week period. intervention 4: Placebo is given in tablet form, a single dose 2 hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a 2-week period.

Protocol document: