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

NCT ID: NCT00322803

Last Updated: 2006-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Panic Disorder

Keywords

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panic disorder proof of concept

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ELB139

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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elbion AG

INDUSTRY

Sponsor Role lead

Principal Investigators

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Eric Griez, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Charité - University Clinics Berlin

Berlin, , Germany

Site Status

Emovis, The institute of emotional health

Berlin, , Germany

Site Status

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

Maastricht, , Netherlands

Site Status

Countries

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Germany Netherlands

Other Identifiers

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EudraCT Number:2005-005708-17

Identifier Type: -

Identifier Source: secondary_id

ELB139202-05

Identifier Type: -

Identifier Source: org_study_id