Last updated: 11/07/2018 01:02:28
Emotional processing in healthy volunteers in the presence of an investigational anxiolytic
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Multiple emotional and psychometric battery of tests
Timeframe: < 1 day
Adverse Events, laboratory values, vital signs, ECGs
Timeframe: < 1 day
Secondary outcomes:
Not applicable
Interventions:
Drug: Citalopram
Drug: GSK424887
Drug: Plactebo To Match
Enrollment:
54
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Catherine J Harmer, Gerry Dawson, Colin Dourish, Elisa Favaron, Lizzie Parsons, Chloe Destoppeleire-Adida, Monica Fiore, Mauro Zucchetto, Angelo Bifone, Italo Poggesi, Sofia Fernandes, Bob Alexander and Guy M Goodwin. Combined NK1 antagonism and serotonin reuptake inhibition: effects on emotional processing in humans. J Psychopharmacol. 2013;27(5):435-443.
Medical condition
Depressive Disorder and Anxiety Disorders
Product
GSK424887
Collaborators
Not applicable
Study date(s)
September 2008 to April 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- 1. Healthy males with no neurological, or history of psychiatric illness
- 2. Aged between 18 and 45 years
- 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
Inclusion and exclusion criteria
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
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
2009-30-04
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.
Additional information about the trial
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