agarophobia with or without panic disorder
Conditions
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of the trial is to investigate if D-Cycloserin augmented exposure therapy reduces agoraphobic symptomatology to a greater extend than placebo augmented exposure therapy.;Secondary Objective: Secondary objectives of the trial are to investigate if D-Cycloserin augmented exposure therapy also leads to greater improvement in other areas of impairment often associated with agoraphobia (depression, mobility ...).;Primary end point(s): Panic and Agoraphobia Scale (PAS);Timepoint(s) of evaluation of this end point: - Visit 1 (within the screening period, days -1 - -56) - Visit 7 (day 29) - Visit 8 (day 57) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Questionnaire on Body Related Fears, Cognitions and Avoidance (BSQ, ACQ, MI) - Beck Anxiety Inventory (BAI) - Anxiety Sensitivity Index (ASI) - Beck Depression Inventory II (BDI II) - Clinical Global Impression (CGI) - Brief Symptom Inventory (BSI) - Visual Analogue Scale (VAS) for Anxiety - Heart Rate Variability (HRV);Timepoint(s) of evaluation of this end point: - Visit 1 (within the screening period, days -1 - -56) - Visit 7 (day 29) - Visit 8 (day 57) - VAS and HRV: Visit 4 (day 8 - 10), 5 (day 15 - 17), and 6 (day 22 - 24). | — |
Countries
Germany
Outcome results
None listed