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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00343707
First received: June 21, 2006
Last updated: May 31, 2012
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Depressive Disorder and Anxiety Disorders
Social Anxiety Disorder
Drug: vestipitant
Drug: paroxetine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 72
Study Start Date: November 2004
Intervention Details:
    Drug: vestipitant Drug: paroxetine
    Other Names:
    • vestipitant
    • paroxetine
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 combination or paroxetine alone on regional cerebral blood flow during a public speaking test in subjects affected by social anxiety disorder.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343707

Locations
Sweden
GSK Investigational Site
Uppsala, Sweden, SE-753 23
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00343707     History of Changes
Other Study ID Numbers: NKP102280
Study First Received: June 21, 2006
Last Updated: May 31, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:
Social Anxiety Disorder
brain imaging
Positron Emission Tomography
antidepressant

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Depressive Disorder
Depression
Phobic Disorders
Mental Disorders
Pathologic Processes
Mood Disorders
Behavioral Symptoms
Paroxetine
Vestipitant
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Neurokinin-1 Receptor Antagonists

ClinicalTrials.gov processed this record on September 18, 2014