Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
schizophrenia, L-Arginine, nitric oxide, drug augmentation
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.
Interventions
DIETARY_SUPPLEMENTL-Arginine
Experimental supplement
OTHERPlacebo
Placebo capsules in the same color and shape with the experimental supplement
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in creatinine | baseline and week 7 | — |
| Change from baseline in sodium | 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 calcium | 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 total cholesterol | 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 |
| 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 heart rate | baseline and week 7 | — |
| Change from baseline in temperature | baseline and week 7 | — |
| Change from baseline in respiratory rate | baseline and week 7 | — |
| Change from baseline in weight | baseline and week 7 | — |
| Change from baseline in electrocardiogram | 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 alkaline phosphatase | baseline and week 7 | — |
| Change from baseline in urea | baseline and week 7 | — |
Countries
Turkey (Türkiye)
Outcome results
None listed