Trial | NCT00322803  Report issue

Title

ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment
International, Multicenter, Randomized, Double-Blind, Placebo Controlled, Two-Period, Cross-Over Study to Demonstrate Safety, Tolerability and Anxiolytic Effects of 600 mg ELB139 Given Orally t.i.d. to Patients With Concurrent Panic Disorder, Challenged by Inhalation of 35% CO2 After a Single Dose and One Week of Treatment

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    elb-139 ...

  • Study Participants

    24
This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35% CO2 measured by a visual analogue scale after the first intake and after approximately one week of treatment as compared to placebo treatment.
Study Started
May 31
2006
Study Completion
Oct 31
2006
Last Update
Sep 29
2006
Estimate

Drug ELB139

Criteria 

Inclusion Criteria:

Diagnosis of concurrent panic disorder
At least 2 panic attacks within the 4 weeks before the screening visit
Naïve to the CO2 challenge test
Age 18-65 years (inclusive)
Ability to comply with all procedures mandated by the study protocol
Negative pregnancy test and adequate contraceptive measures

Exclusion Criteria:

History of poly-pharmacotherapy for panic disorder or treatment resistance
Any current psychiatric Axis I DSM-IV diagnosis other than panic disorder, except concurrent simple phobia
History of abuse of benzodiazepines or tolerance to effects of benzodiazepine
Any concomitant psychotropic medication
Evidence of impaired hepatic, renal or cardiac functions
Participation in any drug trial in the preceding 6 months
No Results Posted