Exploratory Study on the Mood and Cytokine Levels in Female Healthy Participants and Major Depressive Disorder Patients

March 27, 2014 updated by: Janssen Pharmaceutica N.V., Belgium

A 2-way Crossover Study to Explore the Effect of an Inflammatory and Psychosocial Stressor and a Combination Thereof on the Mood and Cytokine Levels in Young and Elderly Healthy Female Subjects and Female Subjects With Major Depressive Disorder

The purpose of this study is to explore the effect of an inflammatory and a psychosocial stressor and the combination thereof on mood in healthy young and elderly participants and patients with Major Depressive Disorder (MDD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a 2-way crossover (method used to switch patients from one treatment arm to another in a clinical study), randomized (the study medication is assigned by chance), placebo-controlled (an inactive substance that is compared with a study medication to test whether the medication has a real effect in a clinical study) study in 3 cohorts (group of individuals with similar characteristics) ie, 18 healthy young female participants; 18 healthy elderly female participants; 18 female patients with a past history of MDD. Participants will be randomized to 1 of 6 possible treatment groups: Group 1: Treatment AB, Group 2: Treatment BA, Group 3: Treatment AC, Group 4: Treatment CA, Group 5: Treatment AD, Group 6: Treatment DA, where Treatment A is placebo vaccination, Treatment B is typhoid vaccination, Treatment C is psychosocial stress (Trier Social Stress Test [TSST]) followed by placebo vaccination, and Treatment D is psychosocial stress (TSST) followed by typhoid vaccination. Participants from each of the 3 cohorts will be randomized to these 6 treatment groups. In all the 6 groups the 1st treatment comes under Period 1 and 2nd treatment under Period 2 (eg, In Group 1: Treatment A [Period 1] and Treatment B [Period 2]) and there will be a minimally 7- and maximally 14- day washout period (period when no treatment is received) between the study periods. The study will consist of an eligibility screening examination (from 21 to 2 days prior to Day 1 of Period 1); a run-in visit (only prior to Period 1) in which eligible participants will be briefly explained about the cognitive test battery and immediately thereafter the baseline of cognitive function will be measured via these tests; 2 single-blind (a clinical study in which the person giving the treatment, but not the patient, knows which treatment the patient is receiving) treatment periods (2-way crossover); and a follow-up examination by phone (approximately 7 to 14 days after last treatment [Period 2]). For each participant, the maximal study duration will not exceed 8 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Duffel, Belgium
      • Leuven, Belgium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • Has body mass index (BMI) [weight in kilograms / (height in meters x height in meters)] between 18 and 30 kg/m2
  • For young healthy participants: female, 25 to 45 years of age; elderly healthy participants: female: ≥ 65 years of age & with baseline C-reactive protein (CRP) > 5 mg/mL; (partially) remitted MDD patients: female, 25 to 45 years of age
  • Inclusion criteria specific for patients with MDD: -Patients with a history (within 24 months) of MDD must have a Montgomery-Asberg Depression Rating Scale (MADRS) total score < 15 and symptom remission (temporary absence of disease symptoms) relative to the acute episode must have been present for at least 3 months

Exclusion Criteria:

  • Has a current Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) axis I diagnosis (other than MDD)
  • Has recently experienced a psychosocial stressor within 6 months
  • Has acute symptoms of suicidality (the likelihood of an individual completing suicide)
  • Has a DSM-IV diagnosis of substance abuse or dependence within 6 months prior to screening evaluation
  • Has been exposed to an experimental medication or experimental medical device within 90 days before screening
  • Has a serology (scientific study of blood serum and other bodily fluids) positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or HIV antibodies at screening
  • Has been exposed to typhoid or typhoid vaccine within 5 years before screening
  • Has been prior exposed to the Trier Social Stress Test (TSST)
  • Has received electroconvulsive therapy (shock therapy) within 3 months before screening
  • Has been involuntarily committed to psychiatric hospitalization
  • Has donated 1 or more units (approximately 450 mL) of blood or had an acute loss of an equivalent amount of blood within 90 days prior to study medication administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Group 1
Treatment AB: Treatment A (Placebo vaccination) administered [Period 1], after the washout period (7-14 days) Treatment B (typhoid vaccination) administered [Period 2]
Biological: Placebo
Placebo is Treatment A and C. Form=saline solution for intramuscular (IM) injection (Injection of a solution into a muscle), route = IM, Unit = mL, number = 0.5 administered on Day 1 of Period 1 and Period 2.
Biological: Salmonella typhi vaccine (Typhim Vi)
Salmonella typhi vaccine (typhoid vaccination) in Treatment B and D; Unit = mg, number = 0.025, form = solution for intramuscularly (IM) injection, route = IM administered on Day 1 of Period 1 and Period 2.
Other: Group 2
Treatment BA: Treatment B (typhoid vaccination) administered [Period 1], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered [Period 2]
Biological: Placebo
Placebo is Treatment A and C. Form=saline solution for intramuscular (IM) injection (Injection of a solution into a muscle), route = IM, Unit = mL, number = 0.5 administered on Day 1 of Period 1 and Period 2.
Biological: Salmonella typhi vaccine (Typhim Vi)
Salmonella typhi vaccine (typhoid vaccination) in Treatment B and D; Unit = mg, number = 0.025, form = solution for intramuscularly (IM) injection, route = IM administered on Day 1 of Period 1 and Period 2.
Other: Group 3
Treatment AC: Treatment A (Placebo vaccination) administered [Period 1], after the washout period (7-14 days) Treatment C (TSST+Placebo vaccination) administered [Period 2]
Biological: Placebo
Placebo is Treatment A and C. Form=saline solution for intramuscular (IM) injection (Injection of a solution into a muscle), route = IM, Unit = mL, number = 0.5 administered on Day 1 of Period 1 and Period 2.
Other: Group 4
Treatment CA: Treatment C (TSST+Placebo vaccination) administered [Period 1], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered [Period 2]
Biological: Placebo
Placebo is Treatment A and C. Form=saline solution for intramuscular (IM) injection (Injection of a solution into a muscle), route = IM, Unit = mL, number = 0.5 administered on Day 1 of Period 1 and Period 2.
Other: Group 5
Treatment AD:Treatment A (Placebo vaccination) administered [Period 1], after the washout period (7-14 days) Treatment D (TSST+typhoid vaccination) administered [Period 2]
Biological: Placebo
Placebo is Treatment A and C. Form=saline solution for intramuscular (IM) injection (Injection of a solution into a muscle), route = IM, Unit = mL, number = 0.5 administered on Day 1 of Period 1 and Period 2.
Biological: Salmonella typhi vaccine (Typhim Vi)
Salmonella typhi vaccine (typhoid vaccination) in Treatment B and D; Unit = mg, number = 0.025, form = solution for intramuscularly (IM) injection, route = IM administered on Day 1 of Period 1 and Period 2.
Other: Group 6
Treatment DA:Treatment D (TSST+typhoid vaccination) administered [Period 1], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered [Period 2]
Biological: Placebo
Placebo is Treatment A and C. Form=saline solution for intramuscular (IM) injection (Injection of a solution into a muscle), route = IM, Unit = mL, number = 0.5 administered on Day 1 of Period 1 and Period 2.
Biological: Salmonella typhi vaccine (Typhim Vi)
Salmonella typhi vaccine (typhoid vaccination) in Treatment B and D; Unit = mg, number = 0.025, form = solution for intramuscularly (IM) injection, route = IM administered on Day 1 of Period 1 and Period 2.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Profile of Mood States (POMS) scores from Baseline to Day 1 of Period 1 and Period 2.
Time Frame: Baseline (pretreatment), Day 1 of Period 1 and Period 2.
Participants score on a scale ranging from 0 (not at all) to 4 (extremely) any of 30 statements related to their mood / energy level by circling the appropriate number.
Baseline (pretreatment), Day 1 of Period 1 and Period 2.
Change in Visual Analogue Scale (VAS) scores from Baseline to Day 1 of Period 1 and Period 2.
Time Frame: Baseline (pretreatment), Day 1 of Period 1 and Period 2.
Participants rate the way they feel on a 10 mm line separating statements along the extremes of different dimensions (eg, alert - drowsy).
Baseline (pretreatment), Day 1 of Period 1 and Period 2.
Change in Snaith-Hamilton Pleasure Scale (SHAPS) scores from Baseline to Day 1 of Period 1 and Period 2.
Time Frame: Baseline (pretreatment), Day 1 of Period 1 and Period 2.
Participants endorse any of 14 statements in 4 categories (Strongly Agree, Agree, Disagree, Strongly Disagree) by ticking the appropriate answer.
Baseline (pretreatment), Day 1 of Period 1 and Period 2.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from Baseline to Day 1 of Period 1 and Period 2.
Time Frame: Baseline (pretreatment), Day 1 of Period 1 and Period 2.
The MADRS is used by trained blinded site staff to rate the severity of depression. It consists of 10 items. The minimal rating is 0 (absent) and the maximal rating is 6 (most serious).
Baseline (pretreatment), Day 1 of Period 1 and Period 2.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Cognitive Test Battery performance from Baseline to Day 1 of Period 1 and Period 2.
Time Frame: Baseline (≤ Day -1 [1 day before starting study drug]), Day 1 of Period 1 and Period 2.
Performance in cognitive tests after the inflammatory (vaccination) and psychosocial stressor and the combination thereof. The cognitive domains to be tested include attention, emotional bias, memory, and executive functioning.
Baseline (≤ Day -1 [1 day before starting study drug]), Day 1 of Period 1 and Period 2.
Changes in levels of hormones and cytokines from Baseline to Day 1 of Period 1 and Period 2.
Time Frame: Baseline (pretreatment), Day 1 of Period 1 and Period 2.
Changes in levels of hormones and cytokines after the inflammatory (vaccination) and psychosocial stressor and the combination thereof. Approximately 10 mL of blood samples from veins must be collected for the assessment of hormones and cytokines (protein released by cells in blood) related to inflammation and depression (or other relevant neuropsychiatric disorders).
Baseline (pretreatment), Day 1 of Period 1 and Period 2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Pharmaceutica N.V., Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR100698
  • NOCOMPOUNDEDI0002 (Other Identifier: Janssen Pharmaceutica N.V.)
  • 2011-004898-80 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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