Major Depressive Disorder Clinical Trial
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
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).
Status | Completed |
Enrollment | 40 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Pharmaceutica N.V., Belgium |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Primary | 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. | No |
Primary | 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. | No |
Primary | 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. | No |
Secondary | 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. | Baseline (= Day -1 [1 day before starting study drug]), Day 1 of Period 1 and Period 2. | No |
Secondary | 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). | Baseline (pretreatment), Day 1 of Period 1 and Period 2. | No |
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