RESOLVING THE NEUROBIOLOGICAL MECHANISMS OF ANXIETY DISORDERS – BRAIN IMAGING SUB-STUDY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005366-30-FI

Enrollment

Registered

2016-06-29

Start date

2016-09-05

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety disorder MedDRA version: 19.0 Level: PT Classification code 10041242 Term: Social anxiety disorder System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: Escitalopram Pharmaceutical Form: Tablet INN or Proposed INN: ESCITALOPRAM Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 20- Pharmaceutical form of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Social anxiety disorder, age 18-65 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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, ß-blockers or daytime benzodiazepines (a small dose of =10mg zolpidem once daily is permissible).

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: Not applicable;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) ;Timepoint(s) of evaluation of this end point: According to the research plan, at week one and eight.	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: Not applicable;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) ;Timepoint(s) of evaluation of this end point: According to the research plan, at week one and eight.

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Finland

Contacts

Public ContactJesper Ekelund

University of Helsinki

jesper.ekelund@helsinki.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026