INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder

ConditionsMajor Depressive Disorder Inflammation

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversiteit Antwerpen

About this trial

This is a randomised, double-blind, placebo-controlled clinical trial in which patients with major depressive disorder will receive augmentation through minocycline (MCO), celecoxib (CXB) or placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, 18-65 years inclusive.

Able and willing to give informed consent and take oral medication.

Physically healthy.

Diagnosis of Major Depressive Disorder by DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI).

Disqualifiers

Primary diagnosis of a bipolar disorder, psychotic spectrum disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or alcohol and/or substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (< 4 weeks before screening, excl. nicotine and caffeine).

Use of immunosuppressant or immunostimulant drugs within 21 days of screening (e.g., glucocorticoid treatment, methotrexate, etc.).

History of peptic ulcer disease or gastrointestinal (GI) bleeding.

Having an acute infection or inflammatory bowel disorder.

Trial design

Design model

Parallel

Treatments tested in this trial

Celecoxib
Drug
Oral capsule, 200 mg, twice daily, for 12 weeks
Minocyclin
Drug
Oral capsule, 100 mg, twice daily, for 12 weeks
Placebo
Drug
Oral capsule, no active substance, twice daily, for 12 weeks

Treatment groups

240 Participants

are divided into 6 treatment groups

Treatment groups

See each treatment group below.

Group A: High Sensitive C-reactive Protein (hs-CRP) < 3mg/L: Minocyclin + Treatment As Usual (TAU)Active comparator 1 intervention

Group B: High Sensitive C-reactive Protein (hs-CRP) < 3mg/L: Celecoxib + Treatment As Usual (TAU)Active comparator 1 intervention

Group C: High Sensitive C-reactive Protein (hs-CRP) < 3mg/L: Placebo + Treatment As Usual (TAU)Placebo comparator 1 intervention

Group D: High Sensitive C-reactive Protein (hs-CRP) > 3mg/L: Minocyclin + Treatment As Usual (TAU)Active comparator 1 intervention

Group E: High Sensitive C-reactive Protein (hs-CRP) > 3mg/L: Celecoxib + Treatment As Usual (TAU)Active comparator 1 intervention

Group F: High Sensitive C-reactive Protein (hs-CRP) > 3mg/L: Placebo + Treatment As Usual (TAU)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in depressive symptom severity (HDRS-17)

Change in severity of depression measured as the change in the 17-point scale of the Hamilton Depression Rating Scale (HDRS-17; score is ranging from 0 to 52, higher scores indicate higher severity of depressive symptoms) between baseline and endpoint

Time frame

T0 -> T6 (12 weeks)

Remission rate of depression (HDRS-17)

Rates of remission measured as a score of ≤7 on the 17-point scale of the Hamilton Depression Rating Scale (HDRS-17; score is ranging from 0 to 52, higher scores indicate higher severity of depressive symptoms and scores 0-7 are considered as being normal) at endpoint

Time frame

T0 -> T6 (12 weeks)

Secondary outcomes

Change in depressive symptom severity (IDS-30SR)

Change in severity of depression measured as the change in the Inventory of Depressive Symptomatology - Self Report (IDS-SR; score is ranging from 0 to 84, higher scores indicate higher severity of depressive symptoms)

Time frame

T0 -> T6 (12 weeks)

Response rate of depressive symptoms (HDRS-17)

Response rates of the depressive symptoms measured on the 17-point scale of the Hamilton Depression Rating Scale (HDRS-17; score is ranging from 0 to 52, higher scores indicate higher severity of depressive symptoms), with response being defined as a 50% reduction in HDRS-17-score from baseline and partial response as a 25% reduction.

Time frame

T0 -> T6 (12 weeks)

Change in night-time sleep (PSQI)

Change in night-time sleep quality and/or quantity measured on the Pittsburgh Sleep Quality Index (PSQI; score is ranging from 0 to 21, higher scores indicate more sleep disturbances)

Time frame

T0 -> T6 (12 weeks)

Change in anxiety (STAI)

Change in anxiety measured on the Stait Trait Anxiety Inventory-Self Report (STAI; score is ranging from 20 tot 80, higher scores indicate higher levels of anxiety intensity)

Time frame

T0 -> T6 (12 weeks)

Other outcomes

Immune markers

Cytokines: interleukin-6, interleukin-1β, tumor necrosis factor α, interferon γ, Interleukin-1 receptor, interleukin-7

Time frame

T0 -> T6 (12 weeks)

Alternate immune markers

Peripheral blood monocytes (PBMCs)

Time frame

T0 -> T6 (12 weeks)

Tryptophan pathway metabolites

Kynurenine (KYN), Kynurenic Acid (KYNA), Quinolinic Acid (QA), 3-Hydroxykynurenine (3-HK)

Time frame

T0 -> T6 (12 weeks)

Vascular and (neuro)trophic factors

Vascular endothelial growth factor (VEGF), Brain-derived neurotrophic factor (BDNF)

Time frame

T0 -> T6 (12 weeks)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universiteit Antwerpen

Lead sponsor

Research Foundation Flanders

Collaborator

KU Leuven

Collaborator

Vrije Universiteit Brussel

Collaborator

Amsterdam UMC, location VUmc

Collaborator

Source ClinicalTrials.gov

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