E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10041242 |
E.1.2 | Term | Social anxiety disorder |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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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 |
Kyseessä on laajan tutkimusohjelman aivokuvantamisosio. Ohjelman tavoitteena on ymmärtää ahdistuneisuushäiriöiden neurobiologiaa paremmin. Tässä osiossa kuvataan ahdistuneisuudesta kärsivien ihmisten aivojen toimintaa sekä MEG että fMRI menetelmin samalla kun he prosessoivat erilaisia visuaalisia ja auditiivisia stimuluksia. Tutkimme koehenkilöt ennen hoitoa ja hoidon jälkeen. Hoito on joko lumetta, tavanomaista lääkettä tai psykososiaalista interventiota viikon ajan. Otamme myös verinäytteen geeniekspressioanalyysia varten. |
Kyseessä on laajan tutkimusohjelman aivokuvantamisosio. Ohjelman tavoitteena on ymmärtää ahdistuneisuushäiriöiden neurobiologiaa paremmin. Tässä osiossa kuvataan ahdistuneisuudesta kärsivien ihmisten aivojen toimintaa sekä MEG että fMRI menetelmin samalla kun he prosessoivat erilaisia visuaalisia ja auditiivisia stimuluksia. Tutkimme koehenkilöt ennen hoitoa ja hoidon jälkeen. Hoito on joko lumetta, tavanomaista lääkettä tai psykososiaalista interventiota viikon ajan. Otamme myös verinäytteen geeniekspressioanalyysia varten. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Social anxiety disorder, age 18-65 |
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E.4 | Principal exclusion criteria |
Exclusion criteria are: borderline, schizoid or schizotypal personality, bipolar or any psychotic disorder; lifetime substance dependence, last-year substance abuse, last month over 24/16 standard doses of alcohol/week; last month use of any illicit substance or last 3 month use of cannabis; unstable somatic illness; antidepressant medication use in last 4 months and use of antipsychotics, mood stabilizers, systemic corticosteroids, β-blockers or daytime benzodiazepines (a small dose of ≤10mg zolpidem once daily is permissible). |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) To characterize whether local and inter-areal oscillatory dynamics are modulated by anxiety (MEG).
2) To characterize whether brain critical dynamics are modulated by anxiety (MEG)
3) To study whether there are specific and/or common effects of various treatments on the neural activation pattern caused by processing of various stimuli (fMRI)
4) To study whether these effects mentioned in 3) predict treatment response, or change in other behavioral measures (fMRI, MEG)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
According to the research plan, at week one and eight. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Modifying and modulating factors for efficacy of escitalopram. |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned days | |