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L-arginine add-on Therapy in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT02398279
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
M. Kazim Yazici, 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Dietary Supplement: L-Arginine Other: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: L-Arginine add-on Treatment for Schizophrenia: A Randomized, Double Blind, Placebo Controlled, Cross Over Study
Study Start Date : June 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 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)
Dietary Supplement: L-Arginine
Experimental supplement

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

Experimental: 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)
Dietary Supplement: L-Arginine
Experimental supplement

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




Primary Outcome Measures :
  1. Change from baseline in Positive and Negative Syndrome Scale [ Time Frame: 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 :
  1. Change from baseline in Neuropsychological Test Battery [ Time Frame: 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.

  2. Change from baseline in the The Calgary Depression Scale for Schizophrenia [ Time Frame: 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.

  3. Change from baseline in Clinical Global Impression - Severity [ Time Frame: 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.

  4. Change from baseline in Abnormal Involuntary Movement Scale [ Time Frame: 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.

  5. Change from baseline in Uku Side Effects Rating Scale [ Time Frame: 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.

  6. Change from baseline in blood pressure [ Time Frame: baseline and week 7 ]
  7. Change from baseline in heart rate [ Time Frame: baseline and week 7 ]
  8. Change from baseline in temperature [ Time Frame: baseline and week 7 ]
  9. Change from baseline in respiratory rate [ Time Frame: baseline and week 7 ]
  10. Change from baseline in weight [ Time Frame: baseline and week 7 ]
  11. Change from baseline in electrocardiogram [ Time Frame: baseline and week 7 ]
  12. Change from baseline in complete blood count [ Time Frame: baseline and week 7 ]
    Composed of different measures. Change in any measure indicates impairment in the composite measure

  13. Change from baseline in alanine aminotransferase [ Time Frame: baseline and week 7 ]
  14. Change from baseline in aspartate aminotransferase [ Time Frame: baseline and week 7 ]
  15. Change from baseline in alkaline phosphatase [ Time Frame: baseline and week 7 ]
  16. Change from baseline in urea [ Time Frame: baseline and week 7 ]
  17. Change from baseline in creatinine [ Time Frame: baseline and week 7 ]
  18. Change from baseline in sodium [ Time Frame: baseline and week 7 ]
  19. Change from baseline in potassium [ Time Frame: baseline and week 7 ]
  20. Change from baseline in chloride [ Time Frame: baseline and week 7 ]
  21. Change from baseline in calcium [ Time Frame: baseline and week 7 ]
  22. Change from baseline in thyroid-stimulating hormone [ Time Frame: baseline and week 7 ]
  23. Change from baseline in free T4 [ Time Frame: baseline and week 7 ]
  24. Change from baseline in total cholesterol [ Time Frame: baseline and week 7 ]
  25. Change from baseline in HDL [ Time Frame: baseline and week 7 ]
  26. Change from baseline in LDL [ Time Frame: baseline and week 7 ]
  27. Change from baseline in triglycerides [ Time Frame: baseline and week 7 ]
  28. Change from baseline in human chorionic gonadotropin [ Time Frame: baseline and week 7 ]
    Pregnancy test in women



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398279


Locations
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Turkey
Hacettepe University Faculty of Medicine Department of Psychiatry
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Kazım M Yazıcı, MD Hacettepe University Faculty of Medicine Department of Psychiatry

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M. Kazim Yazici, Professor of Psychiatry, Hacettepe University
ClinicalTrials.gov Identifier: NCT02398279     History of Changes
Other Study ID Numbers: 011D01101013
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by M. Kazim Yazici, Hacettepe University:
schizophrenia
L-Arginine
nitric oxide
drug augmentation
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders