Major Depressive DisorderPhase 1NCT03523767
Effect of Systemic Inflammation on Emotion and Cognition in Patients With Mood Disorder - A Vaccine Study
A Phase 1 study testing S.typhi Injection and Normal Saline Injection in people with Major Depressive Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this pilot study is to investigate and compare the effect of a mild inflammatory stimulus (typhoid vaccine) on immune response, mood and cognition in healthy volunteers compared to patients with history Major Depressive Disorder (MDD) (not currently depressed and no symptoms of depression in the past 6… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- S.typhi Injection and Normal Saline Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2018to 7 Feb 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers, male or female; aged 18-65
- Subjects with history of Major depression (currently asymptomatic - symptom free for more than 6 months)
- Medication free, if not feasible being on antidepressants will be allowed
Who cannot join
- Volunteers who received this vaccine within 3 years or any other vaccine within 3 months
- Patients with existing inflammatory conditions (connective tissue disorder, autoimmune conditions, neoplastic disease, chronic infections, etc.)
- Patients with acute viral or bacterial infection
- Hospitalized patients
- Patients in acute phase of illness
- Current active medical condition that affect brain anatomy, neurochemistry, or function, e.g. liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any brain disorder (seizure disorder, stroke, dementia, degenerative neurologic diseases)
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- History of any brain diseases, including seizures, stroke, meningitis, encephalitis, dementia, degenerative brain diseases, and serious head injury with loss of consciousness
- Family history of hereditary neurologic disorder
- Floating metallic objects in the body
- Pregnancy
- Exposure to regular use of anti-inflammatory drugs in the last one month
- Excessive exercise, consumption of caffeinated beverages or alcohol, high-fat meals 12 hours before testing
- History of tobacco, alcohol, or drug abuse or dependence.
- History of allergic reaction to vaccination or serious allergic reaction to shellfish or egg allergy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study is to investigate and compare the effect of a mild inflammatory stimulus (typhoid vaccine) on immune response, mood and cognition in healthy volunteers compared to patients with history Major Depressive Disorder (MDD) (not currently depressed and no symptoms of depression in the past 6 months).
Read the detailed description
Study design: In this double blind randomized crossover design, each participant will receive saline injection or typhoid vaccine injection at the first study visit, and will then receive the other injection at the second study visit. All participants will undergo study procedures (clinical and imaging) in two separate sessions after each injection given at least 7 days apart (within 10-14 days).
Baseline blood samples will be taken and vital signs will be measured. Participants will be asked to complete the mood questionnaires and computerized reward tasks. Then, injections of normal saline will be administered intramuscularly in the deltoid muscle. At 1.5h, 3h, 4h and 6h after the injection, the subjects will complete the mood questionnaires and vital signs will be assessed. The computer based task will be repeated at 3h.
Between3h and 6h after the injection blood samples will be collected for cytokines measurement. At 4h, a structural magnetic resonance imaging (MRI), and Functional magnetic resonance imaging (fMRI) will be done.
Follow up visits/calls with the patients will be set to check their physical and mood status.
- Conditions
- Major Depressive Disorder
- Being tested
- S.typhi Injection, Normal Saline Injection
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S.typhi InjectionBiological
0.5 ml of S.typhi injection
Normal Saline InjectionBiological
0.5 ml of normal saline injection
| Study group | Role | What they receive |
|---|---|---|
| Typhoid Vaccine, then Normal Saline | Experimental | 0.5 ml of S.typhi injection, then 0.5 ml of normal saline injection Receives: Biological: S.typhi Injection; Biological: Normal Saline Injection |
| Normal Saline, then Typhoid Vaccine | Placebo comparator | 0.5 ml of normal saline injection, then 0.5 ml of S.typhi injection Receives: Biological: S.typhi Injection; Biological: Normal Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inflammation as indicated by cytokines
To compare proinflammatory cytokines (e.g. IL-6, TNF-α, etc) concentration between the experimental (receiving S.typhi vaccine) and the control group (receiving normal saline).
Measured: baseline, 3-6 hours post-injection
Change in depressed mood as indicated by Hamilton Depression Rating Scale (HAM-D) score
To compare the severity of mood symptoms (as scored on the Hamilton Depression Rating Scale) between the experimental and the control group. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity of depressive symptoms. Scores range from 0-53.
Measured: baseline, 3-6 hours post-injection
Level of prefrontal, limbic and striatal cortex activation as indicated by fMRI
Compare prefrontal cortex response to reward anticipation between the experimental and the control group, using fMRI
Measured: 3-6 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start7 Feb 2018
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Why it stopped: Early termination related to COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In this double blind crossover design, each participant will receive saline injection or typhoid vaccine injection at the first study visit, and will then receive the other injection at the second study visit.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sudhakar Selvaraj, The University of Texas Health Science Center, Houston
- Investigators
- Sudhakar Selvaraj, 7134862627, Principal investigator, Prinicpal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523767
- Sponsor's protocol ID
- HSC-MS-16-0496
- Status last verified
- Mar 2023
- First submitted
- 1 May 2018
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systemic Inflammation on Emotion and Cognition in Patients With Mood Disorder - A Vaccine Study
- ClinicalTrials.gov ID
- NCT03523767
- Acronym / sponsor ID
- HSC-MS-16-0496
- Conditions
- Major Depressive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination related to COVID pandemic
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 14 May 2018 (actual)
- 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.
The purpose of this pilot study is to investigate and compare the effect of a mild inflammatory stimulus (typhoid vaccine) on immune response, mood and cognition in healthy volunteers compared to patients with history Major Depressive Disorder (MDD) (not currently depressed and no symptoms of depression in the past 6 months).
Detailed description
Study design: In this double blind randomized crossover design, each participant will receive saline injection or typhoid vaccine injection at the first study visit, and will then receive the other injection at the second study visit. All participants will undergo study procedures (clinical and imaging) in two separate sessions after each injection given at least 7 days apart (within 10-14 days).
Baseline blood samples will be taken and vital signs will be measured. Participants will be asked to complete the mood questionnaires and computerized reward tasks. Then, injections of normal saline will be administered intramuscularly in the deltoid muscle. At 1.5h, 3h, 4h and 6h after the injection, the subjects will complete the mood questionnaires and vital signs will be assessed. The computer based task will be repeated at 3h.
Between3h and 6h after the injection blood samples will be collected for cytokines measurement. At 4h, a structural magnetic resonance imaging (MRI), and Functional magnetic resonance imaging (fMRI) will be done.
Follow up visits/calls with the patients will be set to check their physical and mood status.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In this double blind crossover design, each participant will receive saline injection or typhoid vaccine injection at the first study visit, and will then receive the other injection at the second study visit.
| Arm | Type | Receives |
|---|---|---|
| Typhoid Vaccine, then Normal Saline | Experimental | Biological: S.typhi Injection, Biological: Normal Saline Injection0.5 ml of S.typhi injection, then 0.5 ml of normal saline injection |
| Normal Saline, then Typhoid Vaccine | Placebo comparator | Biological: S.typhi Injection, Biological: Normal Saline Injection0.5 ml of normal saline injection, then 0.5 ml of S.typhi injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers, male or female; aged 18-65
- Subjects with history of Major depression (currently asymptomatic - symptom free for more than 6 months)
- Medication free, if not feasible being on antidepressants will be allowed
Key exclusion criteria (14 listed)
- Volunteers who received this vaccine within 3 years or any other vaccine within 3 months
- Patients with existing inflammatory conditions (connective tissue disorder, autoimmune conditions, neoplastic disease, chronic infections, etc.)
- Patients with acute viral or bacterial infection
- Hospitalized patients
- Patients in acute phase of illness
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 |
|---|---|---|
| S.typhi Injection0.5 ml of S.typhi injection | Biological | Normal Saline, then Typhoid Vaccine, Typhoid Vaccine, then Normal Saline |
| Normal Saline Injection0.5 ml of normal saline injection | Biological | Normal Saline, then Typhoid Vaccine, Typhoid Vaccine, then Normal Saline |
Primary outcome
Change in Inflammation as indicated by cytokines
Time frame: baseline, 3-6 hours post-injection
To compare proinflammatory cytokines (e.g. IL-6, TNF-α, etc) concentration between the experimental (receiving S.typhi vaccine) and the control group (receiving normal saline).
Change in depressed mood as indicated by Hamilton Depression Rating Scale (HAM-D) score
Time frame: baseline, 3-6 hours post-injection
To compare the severity of mood symptoms (as scored on the Hamilton Depression Rating Scale) between the experimental and the control group. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity of depressive symptoms. Scores range from 0-53.
Level of prefrontal, limbic and striatal cortex activation as indicated by fMRI
Time frame: 3-6 hours post-injection
Compare prefrontal cortex response to reward anticipation between the experimental and the control group, using fMRI
Results and safety
The study was stopped early (reason given: Early termination related to COVID pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Sudhakar Selvaraj, 7134862627 principal investigator
Prinicpal Investigator
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 S.typhi Injection and Normal Saline Injection in people with Major Depressive Disorder, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 14 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: stopped early, as of the sponsor's last update on 4 Apr 2023. 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 was stopped early (reason given: Early termination related to COVID pandemic). Results are not available in the source record.
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?
Change in Inflammation as indicated by cytokines (time frame: baseline, 3-6 hours post-injection). The study lists 3 primary outcomes in all. 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 4 Apr 2023.