The role of brain inflammation in depressio

Phase 1

• Conditions: Major depressive disorder; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2017-004624-30-SE
• Lead Sponsor: inköping University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 66

Inclusion Criteria

General inclusions (evaluated through screening under separate protocol 2017/345-32)
1. Age 18 – 65
2. Working knowledge of Swedish
3. Current MDD episode as determined by MINI screening

Tocilizumab augmentation-protocol related inclusions
1. Willingness to provide informed consent (including consent to use baseline data from protocol 2017/345-32), and ability to do so, as evidenced by clinical assessment and a MMSE score = 24
2. Serum IL-6 levels above upper limit of reference interval (evaluated under separate protocol 2017/345-32)
3. Women of childbearing potential (WOCBP) must agree to use a method of contraception that is highly effective for the duration of the study and for 3 months after the intake of the investigational medicinal product. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 61
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

General exclusions (evaluated under separate protocol 2017/345-32):
1. Any medical condition that, in the judgment of the study physician, after appropriate consults if needed, accounts for the symptoms of depression, such as, for example, hypothyroidism, severe anemia, etc.
2. Standard clinical contraindication to MRI scanning of the head according to MRI checklist in Region Östergötland, following additional exams and evaluation by radiologist if needed.
3. Pregnancy
4. Any medical condition that, in the judgment of the study physician and after appropriate consults if needed, is likely to influence cerebral blood flow or gross-level brain activity/anatomy, such as for instance:
a. type-1 diabetes
b. cardiovascular or respiratory disease
c. history of significant head injury
d. hyper-/hypothyroidism
e. epilepsy
5. Current DSM-5 diagnosis of a substance use disorder (moderate – severe, corresponding to DSM-IV substance dependence; not including nicotine), as determined by the MINI interview
6. Current DSM-5 diagnosis of a psychotic disorder (except MDD episode with mood congruent psychotic symptoms)
7. Use of prescription or over-the-counter drugs that could interfere with the objectives of the study (such as ongoing use of steroidal and non-steroidal anti-inflammatory drugs)
8. Additional medication exclusions:
a. For antidepressants
i. new medications started within one month prior to study (two months, in the case of fluoxetine)
ii. increase in dose within one month prior to study
b. For antipsychotics
i. changed dosage within one month prior to study
c. For antiepileptic drugs
i. changed dosage within two months prior to study
d. For mood stabilizers (e.g., lithium)
i. changed dosage within two months prior to study

Tocilizumab augmentation-protocol related exclusions:
1. Presence, as evaluated by laboratory testing and appropriate specialist consult if needed, of multiple sclerosis, inflammatory bowel disease, or human immunodeficiency virus.
2. Recent (within past month) immunization or plan to receive immunization during the duration of the study.
3. Lactation
4. A history of, or current tuberculosis as determined by history, physical exam, blood tests and chest X-rays.
5. A history of, or current severe herpes infection (severe genital herpes, herpes zoster, or herpes encephalitis).
6. Having a high risk of tuberculosis exposure as confirmed by interview
7. Presence of interstitial pulmonary disease (including but not limited to primary or secondary pulmonary fibrosis or sarcoidosis), as determined by history, physical exam and chest X-ray.
8. Presence of hepatitis B or C as determined by laboratory testing
9. Systemic or serious fungal infection
10. A history of clinically significant recurrence of viral or bacterial infections, as determined from medical records and interview will lead to appropriate specialist consult to determine wheth

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified