L-arginine add-on Therapy in Patients With Schizophrenia
- Conditions
- Schizoaffective DisorderSchizophrenia
- Interventions
- Dietary Supplement: L-ArginineOther: Placebo
- Registration Number
- NCT02398279
- Lead Sponsor
- Hacettepe University
- Brief Summary
This study evaluates the addition of L-Arginine to the usual regimen in the treatment of schizophrenia in adults. As a requisite of crossover design, half of the participants started with L-Arginine and the other half with placebo and switched over after a three weeks use and one week of a washout period.
- Detailed Description
L-arginine is the precursor of nitric oxide (NO), a neuromodulator of dopamine, gamma-aminobutyrate (GABA) and glutamate systems. Nitric oxide donors which increase NO levels at the cellular level could improve N-methyl-D-aspartate (NMDA) receptor dysfunction. Using L-arginine could bypass the blocked NMDA receptors and improve the therapeutic efficacy by reversing the dysfunction.
The investigators proposed that using L-Arginine, a dietary supplement in most cultures, might constitute a safe option as an add-on treatment which may display beneficial effects on positive, negative, cognitive and affective symptoms associated with schizophrenia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Schizophrenia-Schizoaffective Disorder
- Clinical Global Impression >4
- Able to take oral medication and likely to comply the required evaluations
- On stable medication regimen for 8 weeks
- Competent and willing to give informed consent
- Uncontrolled medical illness (renal disease, hepatic, cardiac diseases, gout, asthma, diabetes, sickle cell anemia, low-high blood pressure)
- History of Myocardial Infarction (MI)
- History of genital herpes infections/ receiving lysine containing treatments
- Pregnancy/ lactation
- Substance related and Addictive Disorders
- Drugs that might induce hypotension
- Intolerance to L-arginine and ingredients of placebo or L-arginine capsule
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description L-Arginine-First L-Arginine For the first three weeks, L-Arginine 3 g bid (500mg capsules 6 x 2), one week wash-out, then for the next three weeks placebo capsules (6 x 2) L-Arginine-First Placebo For the first three weeks, L-Arginine 3 g bid (500mg capsules 6 x 2), one week wash-out, then for the next three weeks placebo capsules (6 x 2) Placebo-First L-Arginine For the first three weeks, placebo capsules (6 x 2), one week wash-out, then for the next three weeks L-Arginine 3 g bid (500 mg capsules 6 x 2) Placebo-First Placebo For the first three weeks, placebo capsules (6 x 2), one week wash-out, then for the next three weeks L-Arginine 3 g bid (500 mg capsules 6 x 2)
- Primary Outcome Measures
Name Time Method Change from baseline in Positive and Negative Syndrome Scale baseline and week 3 Evaluating change in Positive and Negative Syndrome Scale between baseline and Week 3, comparing subjects treated with L-Arginine for 3 weeks to subjects treated with placebo for 3 weeks.
- Secondary Outcome Measures
Name Time Method Change from baseline in Neuropsychological Test Battery baseline and week 3 Evaluating change in Neuropsychological Test Battery between baseline and Week 3, comparing subjects treated with L-Arginine for 3 weeks to subjects treated with placebo for 3 weeks.
Change from baseline in the The Calgary Depression Scale for Schizophrenia baseline and week 3 Evaluating change in The Calgary Depression Scale for Schizophrenia between baseline and Week 3, comparing subjects treated with L-Arginine for 3 weeks to subjects treated with placebo for 3 weeks.
Change from baseline in Clinical Global Impression - Severity baseline and week 3 Evaluating change in Clinical Global Impression - Severity between baseline and Week 3, comparing subjects treated with L-Arginine for 3 weeks to subjects treated with placebo for 3 weeks.
Change from baseline in Abnormal Involuntary Movement Scale baseline and week 3 Evaluating change in Abnormal Involuntary Movement Scale between baseline and Week 3, comparing subjects treated with L-Arginine for 3 weeks to subjects treated with placebo for 3 weeks.
Change from baseline in Uku Side Effects Rating Scale baseline and week 3 Evaluating change in Uku Side Effects Rating Scale between baseline and Week 3, comparing subjects treated with L-Arginine for 3 weeks to subjects treated with placebo for 3 weeks.
Change from baseline in blood pressure baseline and week 7 Change from baseline in respiratory rate baseline and week 7 Change from baseline in heart rate baseline and week 7 Change from baseline in temperature baseline and week 7 Change from baseline in electrocardiogram baseline and week 7 Change from baseline in weight baseline and week 7 Change from baseline in complete blood count baseline and week 7 Composed of different measures. Change in any measure indicates impairment in the composite measure
Change from baseline in alanine aminotransferase baseline and week 7 Change from baseline in aspartate aminotransferase baseline and week 7 Change from baseline in urea baseline and week 7 Change from baseline in alkaline phosphatase baseline and week 7 Change from baseline in creatinine baseline and week 7 Change from baseline in sodium baseline and week 7 Change from baseline in calcium baseline and week 7 Change from baseline in total cholesterol baseline and week 7 Change from baseline in potassium baseline and week 7 Change from baseline in chloride baseline and week 7 Change from baseline in thyroid-stimulating hormone baseline and week 7 Change from baseline in free T4 baseline and week 7 Change from baseline in HDL baseline and week 7 Change from baseline in LDL baseline and week 7 Change from baseline in triglycerides baseline and week 7 Change from baseline in human chorionic gonadotropin baseline and week 7 Pregnancy test in women
Trial Locations
- Locations (1)
Hacettepe University Faculty of Medicine Department of Psychiatry
🇹🇷Ankara, Turkey