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
2 other identifiers
interventional
24
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2006
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 5, 2006
CompletedFirst Posted
Study publicly available on registry
May 8, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedSeptember 29, 2006
September 1, 2006
May 5, 2006
September 27, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- elbion AGlead
Study Sites (3)
Charité - University Clinics Berlin
Berlin, 10117, Germany
Emovis, The institute of emotional health
Berlin, 10629, Germany
Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
Maastricht, 6200 MD, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Griez, Prof Dr
Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 5, 2006
First Posted
May 8, 2006
Study Start
May 1, 2006
Study Completion
October 1, 2006
Last Updated
September 29, 2006
Record last verified: 2006-09