NCT01533285

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1 major-depressive-disorder

Timeline
Completed

Started May 2012

Shorter than P25 for early_phase_1 major-depressive-disorder

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2012

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

March 28, 2014

Status Verified

March 1, 2014

Enrollment Period

1.5 years

First QC Date

January 19, 2012

Last Update Submit

March 27, 2014

Conditions

Major Depressive Disorder

Keywords

Major depressive disorderMDDPsychiatry disordersPsychosocial stressorPsychosocial stressTyphoid vaccinationTyphoid vaccine

Outcome Measures

Primary Outcomes (4)

  • Change in Profile of Mood States (POMS) scores from Baseline to 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.

    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.

    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.

    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 Outcomes (2)

  • Change in Cognitive Test Battery performance from Baseline to Day 1 of Period 1 and Period 2.

    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.

    Baseline (pretreatment), Day 1 of Period 1 and Period 2.

Study Arms (6)

Group 1

OTHER

Treatment AB: Treatment A (Placebo vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment B (typhoid vaccination) administered \[Period 2\]

Biological: PlaceboBiological: Salmonella typhi vaccine (Typhim Vi)

Group 2

OTHER

Treatment BA: Treatment B (typhoid vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered \[Period 2\]

Biological: PlaceboBiological: Salmonella typhi vaccine (Typhim Vi)

Group 3

OTHER

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

Group 4

OTHER

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

Group 5

OTHER

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: PlaceboBiological: Salmonella typhi vaccine (Typhim Vi)

Group 6

OTHER

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: PlaceboBiological: Salmonella typhi vaccine (Typhim Vi)

Interventions

PlaceboBIOLOGICAL

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.

Group 1Group 2Group 3Group 4Group 5Group 6
Salmonella typhi vaccine (Typhim Vi)BIOLOGICAL

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.

Group 1Group 2Group 5Group 6

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Duffel, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Related Publications (1)

  • Niemegeers P, de Boer P, Schuermans J, Dumont GJH, Coppens V, Spittaels K, Claes S, Sabbe BGC, Morrens M. Digging deeper in the differential effects of inflammatory and psychosocial stressors in remitted depression: Effects on cognitive functioning. J Affect Disord. 2019 Feb 15;245:356-363. doi: 10.1016/j.jad.2018.11.020. Epub 2018 Nov 6.

    PMID: 30423462DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vi polysaccharide vaccine, typhoid

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Janssen Pharmaceutica N.V. Clinical Trial

    Janssen Pharmaceutica N.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2012

First Posted

February 15, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

March 28, 2014

Record last verified: 2014-03

Locations

BE(2)