INSTA-MD: INflammation-based Stratification for immune-Targeted Augmentation in Major Depressive disorder

Conditions

Major Depressive Disorder (MDD)

Brief summary

Change in severity of depression measured as change in the HDRS-17 between baseline and endpoint, Rates of remission (HDRS≤7) at endpoint

Detailed description

Change in severity (IDS-30SR) Change in severity of depression measured as change in the IDS-30SR score [Time Frame: T0 -> T6 (12 weeks)], Response rate (HDRS-17) Rates of response (50% reduction in HDRS score from baseline) or partial response (25% reduction) at endpoint [Time Frame: T0 -> T6 (12 weeks)], Sleep (PSQI) [Time Frame: T0 -> T6 (12 weeks)], Anxiety (STAI) [Time Frame: T0 -> T6 (12 weeks)], Metabolic outcomes BMI, waist circumference, triglyceride, cholesterol, HDL and LDL levels, and fasting glucose [Time Frame: T0 -> T6 (12 weeks)], Symptom profiles (IDS-SR) [Time Frame: T0 -> T6 (12 weeks)], Therapy compliance (MARS) [Time Frame: T0 -> T6 (12 weeks)], Adverse effects [Time Frame: T0 -> T6 (12 weeks)], biomarker outcomes: cytokine concentrations, oxidative stress and metabolic markers, Core assessment of psychomotor change (CORE) [Time Frame: T0 -> T6 (12 weeks)]

Wessa C, Janssens J, Coppens V, El Abdellati K, Vergaelen E, van den Ameele S, Baeken C, Zeeuws D, Milaneschi Y, Lamers F, Penninx B, Claes S, Morrens M, De Picker L.

2024-09-1910 citations

10.1016/j.bbih.2024.100871

Interventions

DRUGMinocycline EG 100 mg Filmtabletten

DRUGCelecoxib EG 200 mg capsules

DRUGhard

DRUGPlacebo

DRUGhard capsule

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change in severity of depression measured as change in the HDRS-17 between baseline and endpoint, Rates of remission (HDRS≤7) at endpoint	—

Secondary

Measure	Time frame
Change in severity (IDS-30SR) Change in severity of depression measured as change in the IDS-30SR score [Time Frame: T0 -> T6 (12 weeks)], Response rate (HDRS-17) Rates of response (50% reduction in HDRS score from baseline) or partial response (25% reduction) at endpoint [Time Frame: T0 -> T6 (12 weeks)], Sleep (PSQI) [Time Frame: T0 -> T6 (12 weeks)], Anxiety (STAI) [Time Frame: T0 -> T6 (12 weeks)], Metabolic outcomes BMI, waist circumference, triglyceride, cholesterol, HDL and LDL levels, and fasting glucose [Time Frame: T0 -> T6 (12 weeks)], Symptom profiles (IDS-SR) [Time Frame: T0 -> T6 (12 weeks)], Therapy compliance (MARS) [Time Frame: T0 -> T6 (12 weeks)], Adverse effects [Time Frame: T0 -> T6 (12 weeks)], biomarker outcomes: cytokine concentrations, oxidative stress and metabolic markers, Core assessment of psychomotor change (CORE) [Time Frame: T0 -> T6 (12 weeks)]	—

Measure

Time frame

Change in severity (IDS-30SR) Change in severity of depression measured as change in the IDS-30SR score [Time Frame: T0 -> T6 (12 weeks)], Response rate (HDRS-17) Rates of response (50% reduction in HDRS score from baseline) or partial response (25% reduction) at endpoint [Time Frame: T0 -> T6 (12 weeks)], Sleep (PSQI) [Time Frame: T0 -> T6 (12 weeks)], Anxiety (STAI) [Time Frame: T0 -> T6 (12 weeks)], Metabolic outcomes BMI, waist circumference, triglyceride, cholesterol, HDL and LDL levels, and fasting glucose [Time Frame: T0 -> T6 (12 weeks)], Symptom profiles (IDS-SR) [Time Frame: T0 -> T6 (12 weeks)], Therapy compliance (MARS) [Time Frame: T0 -> T6 (12 weeks)], Adverse effects [Time Frame: T0 -> T6 (12 weeks)], biomarker outcomes: cytokine concentrations, oxidative stress and metabolic markers, Core assessment of psychomotor change (CORE) [Time Frame: T0 -> T6 (12 weeks)]

—

Countries

Belgium

Outcome results

None listed