Last updated: 11/07/2018 19:37:57
A Study To Compare Emotional Changes In Subjects With Social Anxiety Disorder
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, fMRI and PET Study Comparing Emotional Challenge-induced Regional Cerebral Blood Flow Changes Before and After 8 Weeks of Treatment With Placebo and Paroxetine in Subjects with Social Anxiety Disorder
Trial description: To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
fMRI BOLD response in the amygdala and insula elicited by the Matching Emotional Face paradigm at baseline and after 8 weeks of treatment. State-anxiety inventory (STAI-S) after the Public Speaking challenge (only patients).
Timeframe: baseline and after 8 weeks
Secondary outcomes:
fMRI BOLD response in selected neuroanatomical ROI elicited by the by Resting State and by other exploratory paradigms at baseline (all subjects) and after 8 weeks of treatment with paroxetine compared to placebo (only patients).
Timeframe: baseline and after 8 weeks
Interventions:
Drug: Placebo treatment during 8 weeks
Drug: Paroxetine treatment during 8 weeks
Enrollment:
56
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Mónica Giménez, Hector Ortiz, Carles Soriano-Mas, Marina López-Solà, Magí Farré, Joan Deus, Rocio Martín-Santos, Sofia Fernandes, Paolo Fina, Massimo Bani, Stefano Zancan, Jesús Pujol, Emilio Merlo-Pich, . Functional effects of chronic paroxetine versus placebo on the fear, stress and anxiety neurocircuitry in Social Anxiety Disorder: Initial validtion of an imaging protocol for drug discovery. Eur Neuropsychopharmacol. 2014;24(1):105-116.
Medical condition
Social Phobia
Product
paroxetine
Collaborators
Not applicable
Study date(s)
January 2007 to January 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
- Outpatient with Social Anxiety Disorder
- The subject is healthy
- Subjects with depression or any other psychiatric condition
- Subjects positive for HIV or hepatitis
Inclusion and exclusion criteria
Inclusion criteria:
- Outpatient with Social Anxiety Disorder
- The subject is healthy
- Willing to restrict alcohol intake
- Capable of giving informed consent
Exclusion criteria:
- Subjects with depression or any other psychiatric condition
- Subjects positive for HIV or hepatitis
- Subjects taking drugs or other medication
- Pregnant or becoming pregnant during the study
- Subjects who have donated blood
- Subjects who are left-handed
- Subjects with claustrophobia
- Subjects with an electronic device or ferromagnetic metal foreign body
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-07-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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