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

Sponsored by:	elbion AG
Information provided by:	elbion AG
ClinicalTrials.gov Identifier:	NCT00322803

Purpose

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.

Condition	Intervention	Phase
Panic Disorder	Drug: ELB139	Phase II

MedlinePlus related topics: Anxiety Panic Disorder

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
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

Further study details as provided by elbion AG:

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)

Estimated Enrollment:	24
Study Start Date:	May 2006
Estimated Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322803

Locations

Germany
Charité – University Clinics Berlin
Berlin, Germany, 10117
Emovis, The institute of emotional health
Berlin, Germany, 10629
Netherlands
Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
Maastricht, Netherlands, 6200 MD

Sponsors and Collaborators

elbion AG

Investigators

Principal Investigator:

Eric Griez, Prof Dr

Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University

More Information

Study ID Numbers:	ELB139202-05, EudraCT Number:2005-005708-17
Study First Received:	May 5, 2006
Last Updated:	September 27, 2006
ClinicalTrials.gov Identifier:	NCT00322803
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by elbion AG:

panic disorder
proof of concept

Study placed in the following topic categories:

Panic Disorder
Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 14, 2009