None listed
Conditions
Brief summary
The hypothesis for this study is that a proportion of patients with schizophrenia may not respond to medication because the medication does not cross the blood brain barrier well enough. The blood brain barrier keeps substances out of the brain and is made up of several parts. One part is a group of proteins called “efflux pumps” or “transporters” which act to pump foreign substances out of the brain, back into the blood stream. We believe that some patients who do not respond to medications for schizophrenia have such fast and efficient efflux pumps that the medications cannot get into the brain effectively. The speed and efficiency of these efflux pumps are determined by the genes for these pumps. The particular pumps that are of interest in this study are called P-glycoprotein (PgP) and Breast Cancer Resistance Protein (BCRP). This study will test the addition of a natural product, quercetin, to the patient’s regular medicine. Quercetin is known to slow down these pumps. The aim of the study is: To show that quercetin has beneficial effects when added to the usual medications used in in schizophrenia Objectives: -To figure out the how quercetin has a beneficial effect. -To identify the symptoms of schizophrenia which responded best to quercetin use -To see if there are groups of genes that indicate fast efflux pumps in patients with schizophrenia who do not improve with the usual medications.
Interventions
Addition of quercetin (600mg) bromelain (200mg) tablets (Quercetain) to current medication regimen in a placebo controlled double blind crossover trial.
Investigational product: Quercetain
Dose: 30mg/kg rounded to nearest whole capsule divided into 2 doses given morning and night. Quercetain is given twice a day for 60 days.
There is no washout period
Quercetain is added to the patient's existing regiment without any changes to the existing medications. All patients are inpatients and are admini
Addition of quercetin (600mg) bromelain (200mg) tablets (Quercetain) to current medication regimen in a placebo controlled double blind crossover trial. Investigational product: Quercetain Dose: 30mg/kg rounded to nearest whole capsule divided into 2 doses given morning and night. Quercetain is given twice a day for 60 days. There is no washout period Quercetain is added to the patient's existing regiment without any changes to the existing medications. All patients are inpatients and are administered their medications by nursing staff as normal ward procedure. Adherence will be monitored by the ward clinical pharmacist by chart review. Total duration: 120 days Crossover at 60 days
Sponsors
University of Western Australia School of Medicine and Pharmacology
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Primary diagnosis of schizophrenia Treatment resistant schizophrenia Absence of centrally mediated side effects e.g. sedation, EPSE Stable medications for 2 months
Exclusion criteria
Allergy to Quercetin or Quercetain (Registered Trademark) Pregnancy or lactation ongoing alcohol and substance abuse, brain damage or severe comorbid medical conditions that is likely to affect the CNS Failure to respond to antipsychotic treatment because of non-adherence to treatment or intolerable side effects Presence of a serious medical condition as defined as a disease that is likely to require an unplanned hospital admission for treatment in the period of the trial. Use of medications which are likely to interact significantly with quercetin including: Digoxin, Verapamil, Cyclosporin, Topotecan, Quinidine, Raitanovir, Methotrexate, Dabigatran, Rivaroxaban. The Principal Investigator will evaluate the potential for interactions between quercetin and medications in the participant’s regimen.
Outcome results
None listed