Precision psychiatry: Anti-inflammatory medication in Immuno-metabolic depression

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

11 Oct 2024 → ongoing

Decision date (initial)

2024-10-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Amsterdam UMC · Hersenstichting

External identifiers

EU CT number

2024-513907-15-01

EudraCT number

2021-003850-21

ClinicalTrials.gov

NCT05415397

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To evaluate whether a 12-week celecoxib treatment (400mg/day) added to treatment as usual (TAU, defined as pharmacotherapy and/or psychotherapy) is more effective in reducing depressive symptoms as measured with the Inventory of Depressive Symptomatology (IDS 30-item self-report version) than placebo in patients aged 18-65yr with major depressive disorder and IMD characteristics (atypical, energyrelated symptoms (≥6 on IDS)(Lamers et al. 2020) and circulating CRP>1mg/L) during 12-week follow-up.

Secondary objectives 1

1. To evaluate whether in patients aged 18-65yr with major depressive disorder and IMD characteristics (atypical, energy-related symptoms (≥6 on AES subscale from IDS) and circulating CRP>1mg/L) a 12-week adjunctive celecoxib treatment (400mg/day) vs placebo is: - more effective in reaching response (defined as 50% reduction in total IDS score) and remission (based on the Mini International Neuropsychiatric Interview [MINI]) - more effective in improving functioning (WHO-DAS), lowering fatigue (CIS), food craving (GFCQ-T), and pain (Numeric Rating Scale) - more effective in lowering atypical-energy related symptoms (IDS atypical, energy-related symptom profile score) To better understand how and for whom celecoxib add-on treatment is effective, several biological makers are assessed: - inflammatory markers (CRP, IL-6, TNFa), cholesterol, triglycerides, glucose, BMI, waist circumference

Conditions and MedDRA coding

Major Depressive Disorder

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age 18-65 years
2. DSM-5 diagnosis of MDD confirmed with clinical interview (MINI)
3. 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
4. IDS score ≥26 and a score ≥6 on atypical, energy-related symptoms scale from IDS
5. CRP>1mg/L
6. 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
7. signed informed consent

Exclusion criteria 6

1. 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
2. ECT in the past 3 months
3. Being on other psychotropic drugs
4. Clinically overt alcohol/drug dependence or other primary psychiatric diagnoses (schizophrenia, schizoaffective, OCD, or bipolar disorder)
5. Chronic use of anti-inflammatory drugs and corticosteroids
6. Not speaking Dutch

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Inventory of Depressive Symptomatology (IDS, 30-item self-report) total score during 12 week follow-up

Secondary endpoints 12

1. response (50% reduction in IDS score)
2. remission (diagnostic interview)
3. Adverse side effects
4. Symptom profiles (atypical, energy-related symptoms IDS)
5. Fatigue (CIS)
6. Food craving (GFCQ-T)
7. Sleep and sleep duration (ESS, sleep duration from PSQI)
8. Anxiety symptoms (GAD7)
9. Functioning (WHO-DAS)
10. Pain (numeric rating scale)
11. Therapy compliance
12. Change in blood levels of CRP, IL-6, TNF-α, cholesterol, triglycerides,glucose

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC Stichting

Sponsor organisation

Amsterdam UMC Stichting

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC Stichting

Contact name

Femke Lamers

Public contact point

Organisation

Amsterdam UMC Stichting

Contact name

Femke Lamers

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications