L-arginine add-on Therapy in Patients With Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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L-Arginine-First

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)

Group Type EXPERIMENTAL

L-Arginine

Intervention Type DIETARY_SUPPLEMENT

Experimental supplement

Placebo

Intervention Type OTHER

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

Placebo-First

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)

Group Type EXPERIMENTAL

L-Arginine

Intervention Type DIETARY_SUPPLEMENT

Experimental supplement

Placebo

Intervention Type OTHER

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

Interventions

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L-Arginine

Experimental supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No