E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
panic disorder and agoraphobia |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
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 |
Changes in neuronal activation patterns of the three measurements of time in the "Extinction Circuit" (eg amygdala, hippocampus, medial prefrontal cortex) |
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E.2.2 | Secondary objectives of the trial |
Influence of DCS on other relevant neural networks (eg space perception and processing), on Habituation to the scanner measured using fMRI questionnaire, neuropsychological parameter (eg memory) and on conditioning and extinction (contingency interview: ratings of CS + / CS, EDA reaction and behavioral learning curves as a measure of the conditioned response as well as modulation of a neural prediction error signal).
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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 trial: "Neural correlates of panic disorder ". Investigation of genetic factors of the disease (panic disorder and agoarphobia) and their impact on the neural activations. |
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E.3 | Principal inclusion criteria |
- Written consent (according to § 40 AMG (1) 3 b)
- diagnosis of panic disorder and / or agoraphobia, severity of disease after at least CGI > 3 "mildly ill"
- age: 18-65 years
- Sufficient ability to communicate with the investigators to answer questions and fill in questionnaires or scales
- Negative pregnancy test and safe contraception during the study (defined as the Pearl Index <1) in premenopausal women
- 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 ingestion of D-cycloserine
- placement in an institution of judicial or administrative order (according to § 40 AMG (1) 4)
- Other 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, congestive heart failure, Zn acute myocardial infarction, cardiac arrhythmia of grade IV or V according to Lown, severe liver or kidney dysfunction, insulin-dependent diabetes, disorders of hematopoiesis
- Pregnancy or lactation
- changes a psychopharmacotherapy within the last 2 weeks, discontinuation of treatment with psychotropic drugs less than 1 week prior to the study or last-time use of benzodiazepines for less than 4 days
- Short-term disturbances of the past day / night cycle
- Disorder-specific psychotherapy
- Participation within the last month prior to enrollment or during participation in the panic-Cyclo study in another study, AMG
- lack of capacity to consent
- Medical circumstances which exclude an fMRI study (eg existence of ferromagnetic metal or pacemakers). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in neuronal activation patterns of the three measurements of time in the "Circuit Extinction"(eg amygdala, hippocampus, medial prefrontal cortex) |
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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
| No |
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 | 3 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |