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

Purpose

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).

Condition	Intervention	Phase
Major Depressive Disorder	Biological: Placebo Biological: Salmonella typhi vaccine (Typhim Vi)	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Janssen Pharmaceutica N.V., Belgium:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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.
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. ] [ Designated as safety issue: No ]
Participants rate the way they feel on a 10 mm line separating statements along the extremes of different dimensions (eg, alert - drowsy).
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. ] [ Designated as safety issue: No ]
Participants endorse any of 14 statements in 4 categories (Strongly Agree, Agree, Disagree, Strongly Disagree) by ticking the appropriate answer.
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. ] [ Designated as safety issue: No ]
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).

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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.
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. ] [ Designated as safety issue: No ]
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).

Estimated Enrollment:	54
Study Start Date:	May 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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. Other Name: Placebo 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 Name: Salmonella typhi vaccine (Typhim Vi)
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. Other Name: Placebo 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 Name: Salmonella typhi vaccine (Typhim Vi)
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 Name: Placebo
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 Name: Placebo
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. Other Name: Placebo 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 Name: Salmonella typhi vaccine (Typhim Vi)
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. Other Name: Placebo 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 Name: Salmonella typhi vaccine (Typhim Vi)

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.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533285

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

JNJ.CT@sylogent.com

Locations

Belgium
	Recruiting
Duffel, Belgium
	Recruiting
Leuven, Belgium

Sponsors and Collaborators

Janssen Pharmaceutica N.V., Belgium

Investigators

Study Director:

Janssen Pharmaceutica N.V. Clinical Trial

Janssen Pharmaceutica N.V.

More Information

Additional Information:

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:	NCT01533285 History of Changes
Other Study ID Numbers:	CR100698, NOCOMPOUNDEDI0002, 2011-004898-80
Study First Received:	January 19, 2012
Last Updated:	June 5, 2013
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Janssen Pharmaceutica N.V., Belgium:

Major depressive disorder
MDD
Psychiatry disorders
Psychosocial stressor

Psychosocial stress
Typhoid vaccination
Typhoid vaccine

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major

Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 18, 2013