L-arginine add-on Therapy in Patients With Schizophrenia

Hacettepe University12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Schizophrenia Schizoaffective Disorder

Interventions

L-ArginineDIETARY_SUPPLEMENT

Experimental supplement

PlaceboOTHER

Placebo capsules in the same color and shape with the experimental supplement

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Hacettepe University Faculty of Medicine Department of Psychiatry

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Change from baseline in Positive and Negative Syndrome Scale

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.