ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment

Phase 2

Terminated

• Conditions: Panic Disorder

• Registration Number: NCT00322803
• Lead Sponsor: elbion AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-05
• Study First Submitted QC: 2006-05-05
• Study First Posted: 2006-05-08
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-27
• Last Update Posted: 2006-09-29
• Study Completion: 2006-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post)
difference of the degree of anxiety measured as the difference between the pre- and post challenge scores on the Visual Analogue Scale for Anxiety (VAS-A-delta)

Secondary Outcome Measures

Name	Time	Method
Difference of the Total Symptoms Score (TSS) measured as the difference between the pre- and post challenge scores (TSS-delta)
Total Symptom Score assessed immediately after CO2 challenge (TSS-post)

Trial Locations

Locations (3)

Charité - University Clinics Berlin; 🇩🇪 Berlin, Germany

Emovis, The institute of emotional health; 🇩🇪 Berlin, Germany

Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University; 🇳🇱 Maastricht, Netherlands