CompletedEarly Phase 1

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

Belgium40 participantsStarted 2012-05

Plain-language 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).

Who can participate

Age range

25 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Profile of Mood States (POMS) scores from Baseline to Day 1 of Period 1 and Period 2.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

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

Trial details

NCT IDNCT01533285

SponsorJanssen Pharmaceutica N.V., Belgium

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Major Depressive Disorder trials