Depressive Disorder and Anxiety DisordersPhase 1NCT01424384
Emotional Processing in Healthy Volunteers in the Presence of an Investigational Anxiolytic
A Phase 1 study testing Citalopram, GSK424887 and Plactebo To Match in people with Depressive Disorder and Anxiety Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder and Anxiety Disorders
- What is being tested?
- Citalopram, GSK424887 and Plactebo To Match
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Sep 2008to 30 Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emotional Processing in Healthy Male Volunteers Treated With GSK424887. A Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study
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.
- Being tested
- Citalopram, GSK424887, Plactebo To Match
- Keywords
- healthy volunteers, Anxiety Disorder, neuropsychological tests
- Medical subject headings
- Depressive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
Neurophysiological testing.
GSK424887Drug
Neurophysiological testing
Plactebo To MatchDrug
Neurophysiological testing
| Study group | Role | What they receive |
|---|---|---|
| Citalopram | Active comparator | Marketed comparitor Receives: Drug: Citalopram |
| Investigational Medicinal Product | Experimental | GSK424887 Receives: Drug: GSK424887 |
| Placebo To Match Treatment | Placebo comparator | Placebo control Receives: Drug: Plactebo To Match |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple emotional and psychometric battery of tests
Measured: < 1 day
Adverse Events, laboratory values, vital signs, ECGs
Measured: < 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study start19 Sep 2008
- Primary completion30 Apr 2009
- Study completion30 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder and Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424384
- Sponsor's protocol ID
- 105012
- Status last verified
- Jul 2017
- First submitted
- 12 Feb 2010
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 23407644
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Processing in Healthy Male Volunteers Treated With GSK424887. A Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study
- ClinicalTrials.gov ID
- NCT01424384
- Acronym / sponsor ID
- 105012
- Keywords
- healthy volunteers, Anxiety Disorder, neuropsychological tests
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2008 (actual)
- Primary completion
- 30 Apr 2009 (actual)
- Study completion
- 30 Apr 2009 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Citalopram | Active comparator | Drug: CitalopramMarketed comparitor |
| Investigational Medicinal Product | Experimental | Drug: GSK424887GSK424887 |
| Placebo To Match Treatment | Placebo comparator | Drug: Plactebo To MatchPlacebo control |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CitalopramNeurophysiological testing. | Drug | Citalopram |
| GSK424887Neurophysiological testing | Drug | Investigational Medicinal Product |
| Plactebo To MatchNeurophysiological testing | Drug | Placebo To Match Treatment |
Primary outcome
Multiple emotional and psychometric battery of tests
Time frame: < 1 day
Adverse Events, laboratory values, vital signs, ECGs
Time frame: < 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Background: PubMed 23407644Harmer 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 105012 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Citalopram, GSK424887 and Plactebo To Match in people with Depressive Disorder and Anxiety Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple emotional and psychometric battery of tests (time frame: < 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01424384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.