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

This study has been terminated.
Sponsor:
Information provided by:
elbion AG
ClinicalTrials.gov Identifier:
NCT00322803
First received: May 5, 2006
Last updated: September 27, 2006
Last verified: September 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by elbion AG:
panic disorder
proof of concept

Additional relevant MeSH terms:
Panic Disorder
Disease
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014