Healthy MenPhase 1NCT02072278
Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects
A Phase 1 study testing Vortioxetine 10 mg, Vortioxetine 20 mg and Escitalopram 15 mg in people with Healthy Men, run by H. Lundbeck A/S at 1 site in France.
Trial summary
To explore a neurophysiological marker (electroencephalography) of cognitive effect of vortioxetine 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
- Healthy Men
- What is being tested?
- Vortioxetine 10 mg, Vortioxetine 20 mg and Escitalopram 15 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Nov 2014
- 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
- The subject has a normal resting EEG at screening visit
- The subject is able to perform tasks with an auditory stimulus
- The subject is not visually impaired - normal prescription glasses are accepted
- The subject has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 pm and midnight.
Who cannot join
- The subject has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomised, Double-blind, Placebo-controlled, Active Comparator, Four-way Crossover Electroencephalography Study Investigating the Effects of Vortioxetine (Lu AA21004) in Healthy Male Subjects
To explore a neurophysiological marker (electroencephalography) of cognitive effect of vortioxetine
- Conditions
- Healthy Men
- Being tested
- Vortioxetine 10 mg, Vortioxetine 20 mg, Escitalopram 15 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vortioxetine 10 mgDrug
Vortioxetine 20 mgDrug
Escitalopram 15 mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine 10 mg | Experimental | encapsulated tablets; 3 daily doses in each treatment period; orally Receives: Drug: Vortioxetine 10 mg |
| Vortioxetine 20 mg | Experimental | encapsulated tablets; 3 daily doses in each treatment period; orally Receives: Drug: Vortioxetine 20 mg |
| Escitalopram 15 mg | Active comparator | encapsulated tablets; 3 daily doses in each treatment period; orally Receives: Drug: Escitalopram 15 mg |
| Placebo | Placebo comparator | capsules; 3 daily doses in each treatment period; orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Battery of EEG measurements
- Peak amplitude and latency of P300
- AUC of qEEG power spectral bands delta, theta, alpha, beta and gamma
- AUC of evoked gamma power spectral band
- Peak amplitude and latency of N200
- Peak amplitude and latency of error related negativity
- Peak amplitudes and latencies in the evoked responses during successful versus non-successful encoding in the verbal memory task between treatments
Measured: The EEG task battery will be conducted on Days -1 and starting 6 hours post-dose on Days 1 and 3 of each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MenStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072278
- Sponsor's protocol ID
- 15835A
- Other IDs
- 2013-004015-53
- Status last verified
- Nov 2014
- First submitted
- 24 Feb 2014
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomised, Double-blind, Placebo-controlled, Active Comparator, Four-way Crossover Electroencephalography Study Investigating the Effects of Vortioxetine (Lu AA21004) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02072278
- Acronym / sponsor ID
- 15835A
- Conditions
- Healthy Men
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (actual)
- First posted
- 26 Feb 2014 (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.
To explore a neurophysiological marker (electroencephalography) of cognitive effect of vortioxetine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine 10 mg | Experimental | Drug: Vortioxetine 10 mgencapsulated tablets; 3 daily doses in each treatment period; orally |
| Vortioxetine 20 mg | Experimental | Drug: Vortioxetine 20 mgencapsulated tablets; 3 daily doses in each treatment period; orally |
| Escitalopram 15 mg | Active comparator | Drug: Escitalopram 15 mgencapsulated tablets; 3 daily doses in each treatment period; orally |
| Placebo | Placebo comparator | Drug: Placebocapsules; 3 daily doses in each treatment period; orally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The subject has a normal resting EEG at screening visit
- The subject is able to perform tasks with an auditory stimulus
- The subject is not visually impaired - normal prescription glasses are accepted
- The subject has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 pm and midnight.
Key exclusion criteria (2 listed)
- The subject has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.
- Other inclusion and exclusion criteria may apply.
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 |
|---|---|---|
| Vortioxetine 10 mg | Drug | Vortioxetine 10 mg |
| Vortioxetine 20 mg | Drug | Vortioxetine 20 mg |
| Escitalopram 15 mg | Drug | Escitalopram 15 mg |
| Placebo | Drug | Placebo |
Primary outcome
Battery of EEG measurements
Time frame: The EEG task battery will be conducted on Days -1 and starting 6 hours post-dose on Days 1 and 3 of each treatment period.
* Peak amplitude and latency of P300 * AUC of qEEG power spectral bands delta, theta, alpha, beta and gamma * AUC of evoked gamma power spectral band * Peak amplitude and latency of N200 * Peak amplitude and latency of error related negativity * Peak amplitudes and latencies in the evoked responses during successful versus non-successful encoding in the verbal memory task between treatments
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 1 Sep 2015.
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
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 Vortioxetine 10 mg, Vortioxetine 20 mg and Escitalopram 15 mg in people with Healthy Men, run by H. Lundbeck A/S at 1 site in France.
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 4 inclusion and 2 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 1 Sep 2015. 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 France. 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?
Battery of EEG measurements (time frame: The EEG task battery will be conducted on Days -1 and starting 6 hours post-dose on Days 1 and 3 of each treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2015.