Depressive Disorder and Anxiety DisordersPhase 1NCT00513565
A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers
A Phase 1 study testing single dose in people with Depressive Disorder and Anxiety Disorders, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will be conducted in healthy volunteers to investigate the effect of single dose GSK561679 on the changes of brain activation, as it compares to an active comparator, lorazepam. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder and Anxiety Disorders
- What is being tested?
- single dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2007to 14 May 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Non-smokers
- Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-29.9 kg/m2
- Normal ECG.
Who cannot join
- Any serious medical disorder or condition.
- Any history of an endocrine disorder.
- Any clinically significant laboratory abnormality.
- History of psychiatric illness.
- Any history of suicidal attempts or behavior.
- History or current diagnosis of acute narrow angle glaucoma.
- Left handed
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
La Jolla, California, 92037
About this study
Official title: A Randomised, Placebo-controlled, Double-dummy, Crossover Design Study to Investigate the Changes of fMRI BOLD Activation Induced by Emotional Activation Paradigms Following Single Doses of GSK561679 and Lorazepam (Comparator) in Healthy Subjects
This study will be conducted in healthy volunteers to investigate the effect of single dose GSK561679 on the changes of brain activation, as it compares to an active comparator, lorazepam.
- Being tested
- single dose
- Keywords
- GSK561679,, single,, dose,, lorazepam,, fMRI,, BOLD,, healthy volunteers
- 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.
single doseDrug
Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
| Study group | Role | What they receive |
|---|---|---|
| placebo arm | Placebo comparator | There are single dose treatment arms of GSK561679, lorazepam as well as placebo. Receives: Drug: single dose |
| GSK561679 arm | Experimental | There are single dose treatment arms of GSK561679, lorazepam as well as placebo. Receives: Drug: single dose |
| lorazepam arm | Active comparator | There are single dose treatment arms of GSK561679, lorazepam as well as placebo. Receives: Drug: single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in fMRI brain activation (BOLD) response in specific brain regions
Measured: conducted the duration of the study
Secondary outcomes (5)
Physiologic changes
Measured: during & after fMRI session
Visual Analogue Scale measurement of physical reactions
Measured: duration of study
Blood level of GSK561679
Measured: collected during fMRI session
Vital signs & ECG recording
Measured: duration of the study
Lab tests for blood & urine
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study start13 Sep 2007
- Primary completion14 May 2009
- Study completion14 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 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
- NCT00513565
- Sponsor's protocol ID
- CRS105510
- Status last verified
- Jul 2017
- First submitted
- 6 Aug 2007
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, Double-dummy, Crossover Design Study to Investigate the Changes of fMRI BOLD Activation Induced by Emotional Activation Paradigms Following Single Doses of GSK561679 and Lorazepam (Comparator) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00513565
- Acronym / sponsor ID
- CRS105510
- Keywords
- GSK561679,, single,, dose,, lorazepam,, fMRI,, BOLD,, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2007 (actual)
- Primary completion
- 14 May 2009 (actual)
- Study completion
- 14 May 2009 (actual)
- First posted
- 8 Aug 2007 (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 study will be conducted in healthy volunteers to investigate the effect of single dose GSK561679 on the changes of brain activation, as it compares to an active comparator, lorazepam.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo arm | Placebo comparator | Drug: single doseThere are single dose treatment arms of GSK561679, lorazepam as well as placebo. |
| GSK561679 arm | Experimental | Drug: single doseThere are single dose treatment arms of GSK561679, lorazepam as well as placebo. |
| lorazepam arm | Active comparator | Drug: single doseThere are single dose treatment arms of GSK561679, lorazepam as well as placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males
- Non-smokers
- Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-29.9 kg/m2
- Normal ECG.
Key exclusion criteria (7 listed)
- Any serious medical disorder or condition.
- Any history of an endocrine disorder.
- Any clinically significant laboratory abnormality.
- History of psychiatric illness.
- Any history of suicidal attempts or behavior.
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 |
|---|---|---|
| single doseSubjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session. | Drug | GSK561679 arm, lorazepam arm, placebo arm |
Primary outcome
Differences in fMRI brain activation (BOLD) response in specific brain regions
Time frame: conducted the duration of the study
5 secondary outcomes
Physiologic changes
Time frame: during & after fMRI session
Visual Analogue Scale measurement of physical reactions
Time frame: duration of study
Blood level of GSK561679
Time frame: collected during fMRI session
Vital signs & ECG recording
Time frame: duration of the study
Lab tests for blood & urine
Time frame: throughout the study
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 21 Jul 2017.
- Results for study CRS105510 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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 single dose in people with Depressive Disorder and Anxiety Disorders, run by GlaxoSmithKline at 1 site in United States.
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 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 21 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 States. 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?
Differences in fMRI brain activation (BOLD) response in specific brain regions (time frame: conducted the duration of the study). 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 21 Jul 2017.