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

NCT01424384 | Completed Phase 1

• 1 other identifier: 105012
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Disorder and Anxiety Disorders

Keywords

healthy volunteers; Anxiety Disorder; neuropsychological tests

Outcome Measures

Primary Outcomes (2)

• Multiple emotional and psychometric battery of tests

  < 1 day

• Adverse Events, laboratory values, vital signs, ECGs

  < 1 day

Study Arms (3)

Citalopram

ACTIVE COMPARATOR

Marketed comparitor

Drug: Citalopram

Investigational Medicinal Product

EXPERIMENTAL

GSK424887

Drug: GSK424887

Placebo To Match Treatment

PLACEBO COMPARATOR

Placebo control

Drug: Plactebo To Match

Interventions

Citalopram DRUG

Neurophysiological testing.

Citalopram

GSK424887 DRUG

Neurophysiological testing

Investigational Medicinal Product

Plactebo To Match DRUG

Neurophysiological testing

Placebo To Match Treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males with no neurological, or history of psychiatric illness
• Aged between 18 and 45 years
• Agree to use contraception
• BMI range of 18 to 33 kg/m²
• Fluent English speakers
• Non smoker or light smoker

You may not qualify if:

• Positive pre-study drug/alcohol screen or regular alcohol consumption
• Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
• On prescription or non prescription drug
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day
• Consumption of large amounts of caffeinated drinks
• Significant hearing impairment
• Previous experience of the emotional test battery experimental procedures

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Oxford, OX3 7JX, United Kingdom

Location

Related 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 NK(1) 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.

  PMID: 23407644 BACKGROUND

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

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders

Interventions

Citalopram; N-(1-(3-chloro-1-naphthalenyl)ethyl)-2-(4-(4-fluorophenyl)-1-methyl-4-piperidinyl)-N-methylacetamide

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: August 29, 2011
• Study Start: September 19, 2008
• Primary Completion: April 30, 2009
• Study Completion: April 30, 2009
• Last Updated: July 7, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)