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

September 27, 2006 updated by: elbion AG

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

elbion AG

Investigators

  • Principal Investigator: Eric Griez, Prof Dr, Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion

October 1, 2006

Study Registration Dates

First Submitted

May 5, 2006

First Submitted That Met QC Criteria

May 5, 2006

First Posted (Estimate)

May 8, 2006

Study Record Updates

Last Update Posted (Estimate)

September 29, 2006

Last Update Submitted That Met QC Criteria

September 27, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELB139202-05
  • EudraCT Number:2005-005708-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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