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Effect of Systemic Inflammation on Emotion and Cognition in Patients With Mood Disorder - A Vaccine Study

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ClinicalTrials.gov Identifier: NCT03523767
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sudhakar Selvaraj, The University of Texas Health Science Center, Houston

Brief 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 months).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Biological: S.typhi Injection Biological: Normal Saline Injection Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description: The study clinician/ nurse will be aware of the nature of the injection. The study subjects and researcher collecting/analyzing the data will remain blinded to the intervention due to the possible confounding effects of the participant expectations and researcher analyzing the data.
Primary Purpose: Basic Science
Official Title: Effect of Systemic Inflammation on Emotion and Cognition in Patients With Mood Disorder - A Vaccine Study
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders

Arm Intervention/treatment
Experimental: Typhoid Vaccine, then Normal Saline
0.5 ml of S.typhi injection, then 0.5 ml of normal saline injection
Biological: S.typhi Injection
0.5 ml of S.typhi injection

Biological: Normal Saline Injection
0.5 ml of normal saline injection

Placebo Comparator: Normal Saline, then Typhoid Vaccine
0.5 ml of normal saline injection, then 0.5 ml of S.typhi injection
Biological: S.typhi Injection
0.5 ml of S.typhi injection

Biological: Normal Saline Injection
0.5 ml of normal saline injection




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523767


Contacts
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Contact: Sudhakar Selvaraj, MBBS,DPhil 7134862627 Sudhakar.Selvaraj@uth.tmc.edu
Contact: Kathryn Durkin, BS 7134862627 kathryn.durkin@uth.tmc.edu

Locations
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United States, Texas
Sudhakar Selvaraj Recruiting
Houston, Texas, United States, 77054
Contact: Sudhakar Selvaraj, MBBS,DPhil    713-486-2627    Sudhakar.Selvaraj@uth.tmc.edu   
Contact: Kathryn Durkin, BS    7134862627    kathryn.durkin@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Sudhakar Selvaraj, 7134862627 Prinicpal Investigator

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Responsible Party: Sudhakar Selvaraj, Sudhakar Selvaraj, MBBS., DPhil (Oxon)., MRCPsych, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03523767     History of Changes
Other Study ID Numbers: HSC-MS-16-0496
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Disease
Inflammation
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Pathologic Processes
Mental Disorders
Vaccines
Immunologic Factors
Physiological Effects of Drugs