E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
agarophobia with or without panic disorder |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 ...). |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
blood analyses in patients enrolled in the sub-study: "neural correlates of panic disorders". Investigation of genetic factors of the disease (panic disorder and agarophobia) |
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E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Panic and Agoraphobia Scale (PAS) |
|
E.5.1.1 | 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) |
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E.5.2 | 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) |
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E.5.2.1 | 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). |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |