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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-19

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Depressive Disorder and Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Citalopram

Marketed comparitor

Group Type ACTIVE_COMPARATOR

Citalopram

Intervention Type DRUG

Neurophysiological testing.

Investigational Medicinal Product

GSK424887

Group Type EXPERIMENTAL

GSK424887

Intervention Type DRUG

Neurophysiological testing

Placebo To Match Treatment

Placebo control

Group Type PLACEBO_COMPARATOR

Plactebo To Match

Intervention Type DRUG

Neurophysiological testing

Interventions

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Citalopram

Neurophysiological testing.

Intervention Type DRUG

GSK424887

Neurophysiological testing

Intervention Type DRUG

Plactebo To Match

Neurophysiological testing

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND

PMID: 23407644 (View on PubMed)

Study Documents

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