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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 September 2016 |
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Main ID: |
NCT00343707 |
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Date of registration:
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21/06/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PET (Positron Emission Tomography)/Public Speaking Study With A Combination Of 2 Medications In Social Anxiety Patients
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Scientific title:
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A Double-blind, Triple Dummy, Placebo-controlled, Randomised, Parallel Group Positron Emission Tomography Study to Investigate the Effects of a 8 Week Administration of GW597599 and Paroxetine Either Alone or in Combination on Regional Cerebral Blood Flow During a Public Speaking Test in Subjects Affected by Social Phobia. |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00343707 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Sweden
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Depressive Disorder and Anxiety Disorders
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Intervention(s)
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Drug: paroxetine
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Drug: vestipitant
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Primary Outcome(s)
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To assess, by mean of Positron Emission Tomography, the degree of regional Cerebral Blood Flow in different brain regions involved in the emotional brain circuit during public speaking task before treatment and after eight weeks of treatment.
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Secondary Outcome(s)
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To assess symptomatic and physiological measures of anxiety induced by the public speaking task and social anxiety symptoms during eight weeks of treatment. To evaluate safety, tolerability and the effect on sexual function of treatment.
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Secondary ID(s)
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NKP102280
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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