D-cycloserine augmented exposure therapy in patients with agoraphobia

• Conditions: agarophobia with or without panic disorder

• Registration Number: EUCTR2011-001398-19-DE
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-30
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Written consent (according to § 40 AMG (1) 3 b)
- diagnosis of agoraphobia, severity of disease according to CGI at least moderately ill
- age: 18-75 years
- Sufficient ability to communicate with the investigators to answer questions and fill in questionnaires or scales
- Negative pregnancy test in premenopausal women and safe contraception during the study (defined as the Pearl Index <1)
- accessibility of the patient (proximity) for treatment and follow-up
- cooperation (compliance) of the patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Known overreaction after administration of DCS
- Existing pharmacotherapy with ethionamide and / or isoniazid
- placement in an institution of judicial or official order (according to § 40 AMG (1) 4)
- other severe psychiatric disorders such as schizophrenia, substance dependence, dementia
- Acute Suicidality
- epilepsy or other diseases of the central nervous system (brain tumor, encephalitis)
- internal diseases such as severe hypertension, de-compensated heart failure, status post acute myocardial infarction, cardiac arrhythmia of grade IV or V according to Lown, severe hepatic or renal disorders, insulin-dependent diabetes mellitus, disorders of hematopoiesis
- Pregnancy or lactation
- changes of a psychopharmacotherapy or discontinuation of treatment with psychotropic drugs less than 4 weeks before study
- Short-term disturbances of the past day / night cycle
- disorder-specific psychotherapy
- Participation in another study within the AMG last few months before enrollment or during the partial exception of the exposure-cycloserine study
- Lack of capacity to consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified