PET (Positron Emission Tomography)/Public Speaking Study With A Combination Of 2 Medications In Social Anxiety Patients

Depressive Disorder and Anxiety Disorders Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343707
• Other study ID #: NKP102280
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2006
• Last updated: September 13, 2016
• Start date: November 2004
• Est. completion date: November 2005

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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, using functional brain imaging readouts (i.e., WAT(Wave Analysis Technology) PET(Positron Emission Tomography)), after one or eight weeks of treatment. The effect of paroxetine alone after one or eight weeks of treatment will also be measured.

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 combination or paroxetine alone on regional cerebral blood flow during a public speaking test in subjects affected by social anxiety disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder and Anxiety Disorders

Intervention

Drug:
• vestipitant

• paroxetine

Locations

Country	Name	City	State
Sweden	GSK Investigational Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.

External Links

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