Phase
Condition
Mood Disorders
Schizotypal Personality Disorder (Spd)
Psychosis
Treatment
Diroximel fumarate (DRF)
Placebo
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 -65 years, diagnosis of schizophrenia (Diagnostic and Statistical Manual ofMental Disorders-5 (DSM-5)
Stable antipsychotic dose (no change for 1 month)
Currently stable with no evidence of relapse within the last 2 months prior to studyenrolment
Minimum of 60 on the Positive and Negative Syndrome Scale (PANSS)
Capacity to provide informed consent
Exclusion
Exclusion Criteria:
History of significant co-morbid medical or neurological disorder including but notlimited to HIV, malignancies, Systemic Lupus Erythematosus, sarcoidosis, autoimmunevasculitis, bone marrow transplantation
Current use of medication that is known to interact with DRF, live vaccines givenwithin the period of DRF treatment, nephrotoxic medication (including but notlimited to aminoglycosides, diuretics, non-steroidal anti-inflammatory drugs,Lithium)
Contraindications to DRF (pregnancy, women of childbearing potential not currentlyusing effective contraception (combined pill (oestrogen & progesterone),progesterone -only with inhibition of ovulation, intrauterine device, intrauterinehormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexualabstinence), breast feeding, severe hepatic impairment, moderate renal impairment,severe active gastrointestinal disease, lymphocyte count - below the Lower Limit ofNormal (LLN) for the local laboratory (e.g 1.30 x109/L LLN for Viapath King'sCollege London), suspected or confirmed progressive multifocal leukoencephalopathy (PML), presence of risk factors for PML (previous and/or current immunosuppressantor immunomodulatory treatment (including natalizumab, other fumaric esters includingDimethyl Fumarate (DMF) (topical or systemic)), serious infection, current or recentherpes virus infection)
Substance dependence/abuse other than to cigarettes
Current high suicide risk
Participation in a clinical study of unlicensed medicines within the previous 30days
Presence/history of other acute or chronic illness that would make participatingunsafe or unsuitable, any contraindication to MRI scanning (e.g. claustrophobia,metallic implants, pacemaker, vascular clips, metal in eyes, pregnancy)
Allergies to any of DRFs ingredients
Taking part in a research study involving an unlicensed medicine within the last 30days
Study Design
Study Description
Connect with a study center
Department of Computer Science, Faculty of Engineering Science, University College London
London, Greater London WC1E 6BT
United KingdomActive - Recruiting
South London and Maudsley NHS Foundation Trust
London, Greater London SE58AZ
United KingdomActive - Recruiting
School of Psychology, University of birmingham
Birmingham, B15 2TT
United KingdomActive - Recruiting
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