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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Panic Disorder

Intervention / Treatment
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* Drug: ELB139


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ELB139|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Symptom Score assessed immediately after CO2 challenge (TSS-post) |  |  | 
| Difference of the Total Symptoms Score (TSS) measured as the difference between the pre- and post challenge scores (TSS-delta) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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panic disorder, proof of concept