Status:
COMPLETED
PET (Positron Emission Tomography)/Public Speaking Study With A Combination Of 2 Medications In Social Anxiety Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder and Anxiety Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This six-arm study is being conducted to measure the effect of a combination of paroxetine and vestipitant on the arousal induced by public speaking in Seasonal Effective Disorder (SAD) patients, usin...
Detailed Description
A double-blind, double dummy, placebo-controlled, randomised, parallel group positron emission tomography study to investigate the effects of a 8 week administration of vestipitant and paroxetine in c...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Social phobic ambulatory subjects, defined according to DSM-IV criteria.
- Must be capable of giving informed consent and can comply with the study requirements.
- Women of childbearing potential must agree to acceptable method of birth control.
- Exclusion criteria:
- Primary diagnosis within the past 6 months of other psychiatric conditions such as major depression or another anxiety disorder.
- Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type.
- Subjects who, in the investigator's judgement pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
- Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine).
- Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG) findings.
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00343707
Start Date
November 1 2004
End Date
November 1 2005
Last Update
September 15 2016
Active Locations (1)
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1
GSK Investigational Site
Uppsala, Sweden, SE-753 23