CELECOXIB for Major Depressive Disorder

Inclusion criteria

• {"criterion_text":"- Age 18-65 years"}
• {"criterion_text":"- DSM-5 diagnosis of MDD confirmed with clinical interview (MINI)"}
• {"criterion_text":"- Currently using pharmacotherapy (SSRI, SNRI, TCA, TetraCA, MAOI, other antidepressants [bupropion, vortioxetine, agomelatine]) and/or psychotherapy. Subjects should be on the current treatment for at least 4 weeks"}
• {"criterion_text":"- IDS score ≥26 and a score ≥6 on atypical, energy-related symptoms scale from IDS"}
• {"criterion_text":"- CRP>1mg/L"}
• {"criterion_text":"- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: o Is not a woman of child bearing potential (WOCBP) o Is a WOCBP and agrees to use, or is already using, a contraceptive method during the intervention period and up to 1 month after the intervention"}
• {"criterion_text":"- signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Contraindications for celecoxib (active peptic ulcers, gastrointestinal bleeding, impaired kidney function (creatinine clearance < 30 ml/min), impaired liver function (ALT > 2x upper limit of normal [ULT]), history of ischemic heart disease or stroke, heart failure, allergic reactions to aspirin/NSAIDs/coxibs, use of anticoagulants"}
• {"criterion_text":"- ECT in the past 3 months"}
• {"criterion_text":"- Being on other psychotropic drugs"}
• {"criterion_text":"- Clinically overt alcohol/drug dependence or other primary psychiatric diagnoses (schizophrenia, schizoaffective, OCD, or bipolar disorder)"}
• {"criterion_text":"- Chronic use of anti-inflammatory drugs and corticosteroids"}
• {"criterion_text":"- Not speaking Dutch"}

Primary endpoints

• {"endpoint_text":"- Inventory of Depressive Symptomatology (IDS, 30-item self-report) total score during 12 week follow-up","definition_or_measurement_approach":"Measured using the Inventory of Depressive Symptomatology (IDS), 30-item self-report version, total score over a 12-week follow-up period."}

Secondary endpoints

• {"endpoint_text":"- response (50% reduction in IDS score)","definition_or_measurement_approach":"Defined as 50% reduction in total IDS score."}
• {"endpoint_text":"- remission (diagnostic interview)","definition_or_measurement_approach":"Assessed by diagnostic interview; secondary objectives state remission based on the Mini International Neuropsychiatric Interview (MINI)."}
• {"endpoint_text":"- Adverse side effects","definition_or_measurement_approach":"Safety/adverse events monitoring as reported during the trial (no further measurement detail provided)."}
• {"endpoint_text":"- Symptom profiles (atypical, energy-related symptoms IDS)","definition_or_measurement_approach":"Measured using IDS atypical, energy-related symptom profile scores from the IDS instrument."}
• {"endpoint_text":"- Fatigue (CIS)","definition_or_measurement_approach":"Measured using the Checklist Individual Strength (CIS)."}
• {"endpoint_text":"- Food craving (GFCQ-T)","definition_or_measurement_approach":"Measured using the GFCQ-T questionnaire."}
• {"endpoint_text":"- Sleep and sleep duration (ESS, sleep duration from PSQI)","definition_or_measurement_approach":"Measured using the Epworth Sleepiness Scale (ESS) and sleep duration derived from the Pittsburgh Sleep Quality Index (PSQI)."}
• {"endpoint_text":"- Anxiety symptoms (GAD7)","definition_or_measurement_approach":"Measured using the GAD-7 instrument."}
• {"endpoint_text":"- Functioning (WHO-DAS)","definition_or_measurement_approach":"Measured using the WHO Disability Assessment Schedule (WHO-DAS)."}
• {"endpoint_text":"- Pain (numeric rating scale)","definition_or_measurement_approach":"Measured using a numeric rating scale for pain."}
• {"endpoint_text":"- Therapy compliance","definition_or_measurement_approach":"Assessed as adherence/compliance to therapy (no additional measurement detail provided)."}
• {"endpoint_text":"- Change in blood levels of CRP, IL-6, TNF-α, cholesterol, triglycerides,glucose","definition_or_measurement_approach":"Laboratory measurement of blood biomarkers including CRP, IL-6, TNF-α, cholesterol, triglycerides, and glucose; secondary objectives also include assessment of BMI and waist circumference."}

Netherlands

Earliest CTIS Part Ii Submission Date

10-10-2024

Latest Decision Or Authorization Date

11-10-2024

Processing Time Days

1

Number Of Sites

1

Number Of Participants

140

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Amsterdam UMC","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Hersenstichting","duties_or_roles":"Source of monetary support","organisation_type":""}