Back to resultsELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment
Primary Purpose
Panic Disorder
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ELB139
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder focused on measuring panic disorder, proof of concept
Eligibility 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
Sites / Locations
- Charité - University Clinics Berlin
- Emovis, The institute of emotional health
- Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
Outcomes
Primary Outcome Measures
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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00322803
Brief Title
ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Terminated
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
elbion AG
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
panic disorder, proof of concept
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ELB139
Primary Outcome Measure Information:
Title
degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post)
Title
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 Measure Information:
Title
Total Symptom Score assessed immediately after CO2 challenge (TSS-post)
Title
Difference of the Total Symptoms Score (TSS) measured as the difference between the pre- and post challenge scores (TSS-delta)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Griez, Prof Dr
Organizational Affiliation
Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - University Clinics Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Emovis, The institute of emotional health
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
City
Maastricht
ZIP/Postal Code
6200 MD
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment
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