Immunological treatment for Schizophrenia
- Conditions
- Treatment-resistant patients with schizophrenia spectrum disorder (SSD)Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2018-004618-17-SE
- Lead Sponsor
- Region Örebro län
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 12
1) Age: 18 to 40 years
2) Duration of psychiatric illness: exceeding 2 years
3) Rated Markedly ill”, Severely ill” or ”Among the most extremely ill patients” on the Clinical Global Impression – Severity scale (CGI-S)
4) Global Assessment of Functioning below 50
5) Current diagnosis according to Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) of SSD (schizophrenia spectrum disorder)
6) Treatment resistance, i.e. failing to remit despite adequate treatments
7) If female and with any risk for pregnancy: willing to use contraceptives.
8) If antipsychotic treatment is prescribed the plasma concentrations of the drug must be tested and shown to be within the therapeutic interval.
9) Subjects should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.
10) Immunoglobulin levels within the normal range
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 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) on-going immunomodulatory treatment
2) pregnancy or breast-feeding
3) weight below 40 kg
4) clinically relevant on-going infection
5) chronic infections
6) positive screening test for hepatitis B, C, HIV, or tuberculosis
7) any change of psychotropic medication within the previous 4 weeks
8) much or very much improved already at baseline according to CGI-I, I i.e. scores of 1 or 2 by the clinician
9) severe heart failure (NYHA grade IV) or other severe heart disease or history of cardiac arrhythmia or myocardial infarction
10) unable to make an informed decision to consent to the trial
11) in compulsory treatment
12) treatment with clozapine within the last 2 months
13) Previous treatments with immunosuppressive agents
14) Malignancy currently or within 2 years prior to inclusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method