L-arginine add-on Therapy in Patients With Schizophrenia

NCT02398279 | Completed

• 1 other identifier: 011D01101013
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; L-Arginine; nitric oxide; drug augmentation

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and week 3

Secondary Outcomes (28)

• Change from baseline in Neuropsychological Test Battery

  baseline and week 3

• Change from baseline in the The Calgary Depression Scale for Schizophrenia

  baseline and week 3

• Change from baseline in Clinical Global Impression - Severity

  baseline and week 3

• Change from baseline in Abnormal Involuntary Movement Scale

  baseline and week 3

• Change from baseline in Uku Side Effects Rating Scale

  baseline and week 3

Study Arms (2)

L-Arginine-First

EXPERIMENTAL

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)

Dietary Supplement: L-Arginine; Other: Placebo

Placebo-First

EXPERIMENTAL

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)

Dietary Supplement: L-Arginine; Other: Placebo

Interventions

L-Arginine DIETARY_SUPPLEMENT

Experimental supplement

L-Arginine-First; Placebo-First

Placebo OTHER

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

L-Arginine-First; Placebo-First

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Medicine Department of Psychiatry

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (4)

• Boger RH. The pharmacodynamics of L-arginine. J Nutr. 2007 Jun;137(6 Suppl 2):1650S-1655S. doi: 10.1093/jn/137.6.1650S.

  PMID: 17513442 BACKGROUND

• Maia-de-Oliveira JP, Trzesniak C, Oliveira IR, Kempton MJ, Rezende TM, Iego S, Baker GB, Dursun SM, Machado-de-Sousa JP, Hallak JE. Nitric oxide plasma/serum levels in patients with schizophrenia: a systematic review and meta-analysis. Braz J Psychiatry. 2012 Oct;34 Suppl 2:S149-55. doi: 10.1016/j.rbp.2012.07.001. English, Portuguese.

  PMID: 23429845 BACKGROUND

• Vayisoglu S, Anil Yagcioglu AE, Yagcioglu S, Karahan S, Karci O, Gurel SC, Yazici MK. Lamotrigine augmentation in patients with schizophrenia who show partial response to clozapine treatment. Schizophr Res. 2013 Jan;143(1):207-14. doi: 10.1016/j.schres.2012.11.006. Epub 2012 Dec 2.

  PMID: 23217729 BACKGROUND

• Kocyigit Y, Yoca G, Karahan S, Ayhan Y, Yazici MK. [L-Arginine Add-On Treatment for Schizophrenia: A Randomized,Double-Blind, Placebo-Controlled, Crossover Study]. Turk Psikiyatri Derg. 2018 Fall;29(3):147-153. Turkish.

  PMID: 30260460 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Arginine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Kazım M Yazıcı, MD

  Hacettepe University Faculty of Medicine Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 25, 2015
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

TU (1)