Emotional Processing in Healthy Volunteers in the Presence of an Investigational Anxiolytic

Depressive Disorder and Anxiety Disorders Clinical Trial

Official title:

Emotional Processing in Healthy Male Volunteers Treated With GSK424887. A Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424384
• Other study ID #: 105012
• Status: Completed
• Phase: Phase 1
• First received: February 12, 2010
• Last updated: July 5, 2017
• Start date: September 19, 2008
• Est. completion date: April 30, 2009

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a phase I, single centre, randomised, double blind, double-dummy, placebo controlled, parallel group single-dose study in healthy volunteers. The purpose of this study is to assess the effect of a single-dose administration of GSK424887, a potent, selective competitive antagonist of the human Neurokinin 1 (NK1) receptor and a potent inhibitor of the human serotonin transporter (SERT), at the maximum dosage of 100 mg versus placebo and versus citalopram (20 mg) on emotional processing in healthy male volunteers. Pharmacokinetics and safety following oral administration of GSK424887 will be also evaluated. An Emotional Test Battery (ETB) previously used to characterise the effects of antidepressants on positive and negative emotion processing in Healthy Volunteers and patients will be used. We hypothesise that GSK424887 will modulate emotional information processing acutely. We anticipate that these effects may be manifest at sub-effective levels of NK1 and SERT receptor occupancy, thus providing pharmacodynamic evidence of the synergistic interaction of the two mechanisms in humans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 30, 2009
• Est. primary completion date: April 30, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy males with no neurological, or history of psychiatric illness

2. Aged between 18 and 45 years

3. Agree to use contraception

4. BMI range of 18 to 33 kg/m²

5. Fluent English speakers

6. Non smoker or light smoker

Exclusion Criteria:

1. Positive pre-study drug/alcohol screen or regular alcohol consumption

2. Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening

3. On prescription or non prescription drug

4. Exposure to more than four new chemical entities within 12 months prior to the first dosing day

5. Consumption of large amounts of caffeinated drinks

6. Significant hearing impairment

7. Previous experience of the emotional test battery experimental procedures

Related Conditions & MeSH terms

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

Intervention

Drug:
• Citalopram
Neurophysiological testing.
• GSK424887
Neurophysiological testing
• Plactebo To Match
Neurophysiological testing

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Harmer CJ, Dawson GR, Dourish CT, Favaron E, Parsons E, Fiore M, Zucchetto M, Bifone A, Poggesi I, Fernandes S, Alexander RC, Goodwin GM. Combined NK1 antagonism and serotonin reuptake inhibition: effects on emotional processing in humans. J Psychopharmacol. 2013 May;27(5):435-43. doi: 10.1177/0269881112472558. Epub 2013 Feb 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiple emotional and psychometric battery of tests		< 1 day
Primary	Adverse Events, laboratory values, vital signs, ECGs		< 1 day

External 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.
•   Results for study 105012 can be found on the GSK Clinical Study Register.