Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00470483
Other study ID # TMT106386
Secondary ID
Status Completed
Phase Phase 1
First received May 3, 2007
Last updated July 13, 2017
Start date January 22, 2007
Est. completion date January 7, 2009

Study information

Verified date July 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date January 7, 2009
Est. primary completion date January 7, 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo treatment during 8 weeks
comparator
Paroxetine treatment during 8 weeks
treatment drug

Locations

Country Name City State
Spain GSK Investigational Site Barcelona

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). baseline and after 8 weeks
Secondary 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). baseline and after 8 weeks
See also
  Status Clinical Trial Phase
Completed NCT02256566 - Cognitive Training for Mood and Anxiety Disorders N/A
Completed NCT01570400 - Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT N/A
Recruiting NCT01388231 - Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice Phase 2/Phase 3
Completed NCT00684541 - Interpretation Modification Program for Social Phobia N/A
Completed NCT00434759 - Social Phobia Intervention Study of Mannheim N/A
Completed NCT00380731 - Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia N/A
Completed NCT03647605 - Pilot Study: VR Mind and VR Mind+ Intervention N/A
Not yet recruiting NCT03241277 - Nonsurgical Periodontal Treatment in Patients With Social Phobia N/A
Completed NCT02648737 - Cognitive Behavioural Therapy for Anxiety Disorders in PD N/A
Completed NCT02294409 - Manualized Group Cognitive-behavioral Therapy for Social Anxiety in First Episode Psychosis N/A
Terminated NCT01979263 - Attention Bias Modification Treatment for Anxious Youth N/A
Completed NCT01463137 - Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder N/A
Completed NCT00774150 - Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study N/A
Completed NCT00264654 - Long-term Study Of Paroxetine in Women and Men Phase 3
Completed NCT00326430 - Residential Cognitive and Interpersonal Therapy for Social Phobia Phase 2/Phase 3
Completed NCT00000389 - Treatment for Anxiety in Children Phase 3
Completed NCT00397722 - Treatment Of Patients With Social Anxiety Disorder Phase 2
Completed NCT02678624 - Project Collabri for Treatment of Anxiety N/A
Completed NCT00564967 - A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy Phase 3
Completed NCT00403962 - A Combination Therapy In Patients With Social Anxiety Disorder Phase 2