IL-6 inhibition in patients with depression and low-grade inflammation: the Insight study

Not Applicable

Completed

• Conditions: Depressive episode; Mental and Behavioural Disorders; Depressive episode, unspecified

• Registration Number: ISRCTN16942542
• Lead Sponsor: Cambridgeshire and Peterborough NHS Foundation Trust

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30244217 protocol (added 31/10/2019) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34729541/ (added 23/01/2024) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/35036964/ (added 23/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-16
• Study Completion: 2022-04-13
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Inclusion criteria for all participants:
1. Able and willing to give informed consent, including consent to share information with the participant’s General Practitioner (GP) and to access GP records
2. Able to understand written and spoken English
3. Able to consent to blood sampling
4. Willing to abstain from strenuous exercise for 72 hours before the assessment visits
5. Age: 20-65 years (inclusive) at the time of eligibility assessment
6. Diagnosis of depression: meet ICD-10 criteria for diagnosis of depression at the time of eligibility assessment
7. Somatic symptom score: =7 at the time of eligibility assessment based on Beck depression inventory II (BDI-II) items 4=lack of pleasure, 15=loss of energy, 16=changes in sleeping pattern, 18=changes in appetite, 19=concentration difficulty, 20=tiredness or fatigue, and 21=loss of interest in sex
8. History of non/slow response to antidepressant: at the time of eligibility assessment receiving treatment with an antidepressant at adequate dose (according to BNF) for at least four weeks

Additional inclusion criteria for intervention cohort:
1. Inflamed: serum/plasma hsCRP level =3mg/

Exclusion Criteria

Exclusion criteria for all participants:
1. Current or lifetime diagnosis of bipolar disorder, psychotic disorder, personality disorder or eating disorder
2. Current suicidal thoughts (BDI II item 9=suicidal thoughts or wishes score 2 or more) or history of suicide attempt, deliberate self-harm, overdose within six months prior to eligibility assessment
3. History of alcohol or substance use disorder (abuse/dependence) within six months prior to eligibility assessment (nicotine and caffeine dependence are not exclusionary)
4. Pregnant or breastfeeding
5. History of serious allergic reaction after any infusion
6. Current use of medication likely to compromise interpretation of immunological data (including, but not limited to, antibiotics, non-steroidal anti-inflammatory drugs, oral/injectable corticosteroids – or any other substances to be determined by the Chief Investigator)
7. Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of eligibility assessment
8. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other opportunistic infections
9. Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active infectious disease, including current or prior malignancy
10. Rheumatic autoimmune disease, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis
11. Uncontrolled hypertension defined as systolic blood pressure > 170 or diastolic blood pressure > 110
12. No history of chickenpox infection or no history of varicella zoster vaccination

Additional exclusion criteria for intervention cohort:
1. Current or past infection with TB, Hepatitis B, Hepatitis C, VZV or HIV confirmed by blood/other test. Chest X-ray will be also done to exclude TB
2. Pregnancy test (for female participants)
3. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in total somatic symptoms score from baseline assessment to around day 14 post-infusion. Somatic symptom score will be constructed by summing scores for seven relevant Beck Depression Inventory II (BDI-II) items (4=lack of pleasure, 15=loss of energy, 16=changes in sleeping pattern, 18=changes in appetite, 19=concentration difficulty, 20=tiredness or fatigue, and 21=loss of interest in sex). Somatic symptoms will be measured using BDI-II at baseline, day 7, 14 and 28 post-infusion.