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

Primary Purpose

Major Depressive Disorder

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

S.typhi Injection

Normal Saline Injection

About this trial

This is an interventional basic science trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Sudhakar Selvaraj

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Typhoid Vaccine, then Normal Saline

Normal Saline, then Typhoid Vaccine

Arm Description

0.5 ml of S.typhi injection, then 0.5 ml of normal saline injection

0.5 ml of normal saline injection, then 0.5 ml of S.typhi injection

Outcomes

Primary Outcome Measures

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).

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03523767

First Posted

May 1, 2018

Last Updated

March 31, 2023

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT03523767

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Terminated

Why Stopped

Early termination related to COVID pandemic

Study Start Date

February 7, 2018 (Actual)

Primary Completion Date

February 7, 2020 (Actual)

Study Completion Date

February 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

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

ParticipantOutcomes 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.

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Typhoid Vaccine, then Normal Saline

Arm Type

Experimental

Arm Description

0.5 ml of S.typhi injection, then 0.5 ml of normal saline injection

Arm Title

Normal Saline, then Typhoid Vaccine

Arm Type

Placebo Comparator

Arm Description

0.5 ml of normal saline injection, then 0.5 ml of S.typhi injection

Intervention Type

Biological

Intervention Name(s)

S.typhi Injection

Intervention Description

0.5 ml of S.typhi injection

Intervention Type

Biological

Intervention Name(s)

Normal Saline Injection

Intervention Description

0.5 ml of normal saline injection

Primary Outcome Measure Information:

Title

Change in Inflammation as indicated by cytokines

Description

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).

Time Frame

baseline, 3-6 hours post-injection

Title

Change in depressed mood as indicated by Hamilton Depression Rating Scale (HAM-D) score

Description

Time Frame

baseline, 3-6 hours post-injection

Title

Level of prefrontal, limbic and striatal cortex activation as indicated by fMRI

Description

Compare prefrontal cortex response to reward anticipation between the experimental and the control group, using fMRI

Time Frame

3-6 hours post-injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sudhakar Selvaraj, 7134862627

Organizational Affiliation

Prinicpal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sudhakar Selvaraj

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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