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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

Tracking Information
First Submitted Date  ICMJE May 1, 2018
First Posted Date  ICMJE May 14, 2018
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE February 7, 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • 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.
  • 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Systemic Inflammation on Emotion and Cognition in Patients With Mood Disorder - A Vaccine Study
Official Title  ICMJE Effect of Systemic Inflammation on Emotion and Cognition in Patients With Mood Disorder - A Vaccine Study
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Biological: S.typhi Injection
    0.5 ml of S.typhi injection
  • Biological: Normal Saline Injection
    0.5 ml of normal saline injection
Study Arms  ICMJE
  • Experimental: Typhoid Vaccine, then Normal Saline
    0.5 ml of S.typhi injection, then 0.5 ml of normal saline injection
    Interventions:
    • Biological: S.typhi Injection
    • Biological: 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
    Interventions:
    • Biological: S.typhi Injection
    • Biological: Normal Saline Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sudhakar Selvaraj, MBBS,DPhil 7134862627 Sudhakar.Selvaraj@uth.tmc.edu
Contact: Kathryn Durkin, BS 7134862627 kathryn.durkin@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03523767
Other Study ID Numbers  ICMJE HSC-MS-16-0496
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sudhakar Selvaraj, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sudhakar Selvaraj, 7134862627 Prinicpal Investigator
PRS Account The University of Texas Health Science Center, Houston
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP