Major Depressive DisorderEarly Phase 1NCT01533285

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

A Early Phase 1 study testing Salmonella typhi vaccine (Typhim Vi) in people with Major Depressive Disorder, run by Janssen Pharmaceutica N.V., Belgium at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 25 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder
What is being tested?: Salmonella typhi vaccine (Typhim Vi)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 2 sitesBelgium
Study dates: May 2012to Nov 2013
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

Study site
Duffel
Study site
Leuven

Other trials in Belgium

About this study

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

Read the 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.

Conditions: Major Depressive Disorder
Being tested: Placebo, Salmonella typhi vaccine (Typhim Vi)
Keywords: Major depressive disorder, MDD, Psychiatry disorders, Psychosocial stressor, Psychosocial stress, Typhoid vaccination, Typhoid vaccine
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.

Study groups in NCT01533285
Study group	Role	What they receive
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] Receives: Biological: Placebo; Biological: 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] Receives: Biological: Placebo; Biological: 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] Receives: 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] Receives: 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] Receives: Biological: Placebo; Biological: 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] Receives: Biological: Placebo; Biological: Salmonella typhi vaccine (Typhim Vi)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Nov 2013

First posted15 Feb 2012 (estimated)
Study startMay 2012
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01533285
Sponsor's protocol ID: CR100698
Other IDs: NOCOMPOUNDEDI0002, 2011-004898-80
Status last verified: Mar 2014
First submitted: 19 Jan 2012
Last updated: 28 Mar 2014
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 30423462

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01533285
Acronym / sponsor ID: CR100698
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder, MDD, Psychiatry disorders, Psychosocial stressor, Psychosocial stress, Typhoid vaccination, Typhoid vaccine
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 15 Feb 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
Group 1	Other	Biological: Placebo, Biological: Salmonella typhi vaccine (Typhim Vi)Treatment AB: Treatment A (Placebo vaccination) administered [Period 1], after the washout period (7-14 days) Treatment B (typhoid vaccination) administered [Period 2]
Group 2	Other	Biological: Placebo, Biological: Salmonella typhi vaccine (Typhim Vi)Treatment BA: Treatment B (typhoid vaccination) administered [Period 1], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered [Period 2]
Group 3	Other	Biological: PlaceboTreatment AC: Treatment A (Placebo vaccination) administered [Period 1], after the washout period (7-14 days) Treatment C (TSST+Placebo vaccination) administered [Period 2]
Group 4	Other	Biological: PlaceboTreatment CA: Treatment C (TSST+Placebo vaccination) administered [Period 1], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered [Period 2]
Group 5	Other	Biological: Placebo, Biological: Salmonella typhi vaccine (Typhim Vi)Treatment AD:Treatment A (Placebo vaccination) administered [Period 1], after the washout period (7-14 days) Treatment D (TSST+typhoid vaccination) administered [Period 2]
Group 6	Other	Biological: Placebo, Biological: Salmonella typhi vaccine (Typhim Vi)Treatment DA:Treatment D (TSST+typhoid vaccination) administered [Period 1], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered [Period 2]

Who may qualify

Ages: 25 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo 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	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6
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.	Biological	Group 1, Group 2, Group 5, Group 6

Primary outcome

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.
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).
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.
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).

2 secondary outcomes

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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
Derived from this study: PubMed 30423462Niemegeers 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.

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Pharmaceutica N.V. Clinical Trial study director

Janssen Pharmaceutica N.V.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Salmonella typhi vaccine (Typhim Vi) in people with Major Depressive Disorder, run by Janssen Pharmaceutica N.V., Belgium at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01533285, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2014.