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

NCT00343707 | Completed Phase 2

• 1 other identifier: NKP102280
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Depressive Disorder and Anxiety Disorders

Keywords

Social Anxiety Disorder; brain imaging; Positron Emission Tomography; antidepressant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

vestipitant DRUG

paroxetine DRUG

Also known as: vestipitant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Uppsala, SE-753 23, Sweden

Location

Related Publications (1)

• Faria V, Ahs F, Appel L, Linnman C, Bani M, Bettica P, Pich EM, Wahlstedt K, Fredrikson M, Furmark T. Amygdala-frontal couplings characterizing SSRI and placebo response in social anxiety disorder. Int J Neuropsychopharmacol. 2014 Aug;17(8):1149-57. doi: 10.1017/S1461145714000352. Epub 2014 Mar 26.

  PMID: 24666527 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Phobia, Social

Interventions

vestipitant; Paroxetine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2006
• First Posted: June 23, 2006
• Study Start: November 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)