E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
panic disorder with agoraphobia |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052794 |
E.1.2 | Term | Panic disorder with agoraphobia |
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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 |
The first aim of the study is whether D-cycloserine (DCS) addition to exposure therapy enhances symptom reduction in panic disorder with agoraphobia. |
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E.2.2 | Secondary objectives of the trial |
The second objective of the study is to establish the optimal timing of administration of DCS (directly pre- or post exposure therapy). The third objective is to study the fear extinction enhancement of DCS using a neuropsychological paradigm. The fourth objective is, from a health economic perspective, to establish cost-effectiveness of DCS. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with DSM-IV criteria for PD+AGO - Male and female, aged between 18-55years old. - Female patients of childbearing potential must use reliable method of contraception and not be planning a pregnancy during the study period (in case of doubt a pregnancy test is provided). - Written informed consent. - Eligible for exposure therapy.
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E.4 | Principal exclusion criteria |
Patients with: - comorbid psychiatric disorder (severe major depressive disorder, bipolar disorder, psychosis, dependence and/or abuse of alcohol/drugs during the past three months) - Mental deficiency - Inability to adequately read or speak Dutch - (a history of) neurological disease (i.e. neurovascular disease, movement disorders, seizures, dementia), renal or liver abnormalities - A history of allergies, adverse reactions or rash on medication - Currently taking benzodiazepines during the day since benzodiazepines might hamper therapy effect (use of stable dosage of evening medication is allowed) - Pregnancy or breastfeeding at the time of the study (in case of doubt a pregnancy test is provided). - Use of isoniazide. - Use of variable dosages of antidepressiva (SSRI's or TCA's). (The use of a fixed dosage is NOT an exclusion criterium, but will be registered). - An unsuccessful evidence based behavioral therapy for panic disorder during the past 12 months (therapy resistant patients).
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E.5 End points |
E.5.1 | Primary end point(s) |
-the Panic Disorder Severity Scale (PDSS; Shear et al. 1997) -the Subjective Unit of Distress Scale (SUDS; Wolpe 1969) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
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 | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |