Last updated: 11/04/2018 09:43:22
PET (Positron Emission Tomography)/Public Speaking Study With A Combination Of 2 Medications In Social Anxiety Patients
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: N/A
Secondary outcomes:
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.
Timeframe: N/A
Interventions:
Drug: vestipitant
Drug: paroxetine
Enrollment:
72
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder and Anxiety Disorders
Product
paroxetine
Collaborators
Not applicable
Study date(s)
November 2004 to November 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Social phobic ambulatory subjects, defined according to DSM-IV criteria.
- Must be capable of giving informed consent and can comply with the study requirements.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-15-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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