Effect of Sarcosine on Symptomatology, Quality of Life, Oxidative Stress and Glutamatergic Parameters in Schizophrenia

NCT01503359 | Completed Phase 2

• 2 other identifiers: PULSARN N402 268836
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of study is to determine whether dietary supplement sarcosine is effective in treatment of schizophrenia. The investigators will assess impact of sarcosine on quality of life and sexual functioning. In this project the investigators will also measure glycine, sarcosine, BDNF, MMP-9 levels and oxydative stress parameters in blood, brain glutamatergic metabolism parameters in magnetic resonance spectroscopy and oculomotoric changes in electrooculography.

Conditions

Schizophrenia

Keywords

glutamic acid; sarcosine; NMDA; schizophrenia

Outcome Measures

Primary Outcomes (1)

• Assessment of sarcosine vs. placebo impact on schizophrenia symptoms using Positive and Negative Syndrome Scale (PANSS).

  Both arms, every visit

  6 months

Secondary Outcomes (7)

• Impact assessment of sarcosine versus placebo on the parameters of quality of life (QoL) and sexual functioning.

  6 months

• Impact assessment of sarcosine versus placebo on depressive symptoms using Calgary Depression Scale for Schizophrenia.

  6 months

• Impact assessment of sarcosine versus placebo on cognitive functions using Wisconsin Card Sort Test, Trail Making Test and Stroop Test.

  6 months

• Impact assessment of sarcosine versus placebo on oxidative stress parameters (T-BARS).

  6 months

• Impact assessment of sarcosine versus placebo on brain metabolism parameters (magnetic resonance spectroscopy).

  6 months

Study Arms (2)

Dietary Supplement: Sarcosine

EXPERIMENTAL

Sarcosine Group

Dietary Supplement: Sarcosine

Placebo

PLACEBO COMPARATOR

Control Group

Dietary Supplement: Sarcosine

Interventions

Sarcosine DIETARY_SUPPLEMENT

Sarcosine group patients will receive 2 grams of sarcosine once a day in the morning for 6 months. Placebo group patients will receive 2 grams of placebo once a day in the morning for 6 months.

Also known as: glycine transporter inhibitor, GlyT1 inhibitor

Dietary Supplement: Sarcosine; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Diagnosis of schizophrenia (ICD-10)
• Other criteria related to the diagnosis verified during the selection visit:
• The score for the PANSS negative symptoms subscale ≥ 21,
• Severity of individual symptoms in the PANSS positive symptoms subscale may not exceed 3 points.

You may not qualify if:

• General
• lack of written informed consent,
• risk of noncompliance during the study period,
• patients who can not be assessed throughout the study period (eg. due to travel or vacations),
• pregnancy or breastfeeding,
• women of childbearing potential not using effective contraception (ie. birth control pill, surgical sterilization, hormonal contraceptive injection, IUD, contraceptive implant, patch, or condoms),
• participation in another clinical study, currently or within 3 months before the visit of a selection panel
• patients previously subjected to selection for this study.
• Medical and Therapeutic Criteria Associated with schizophrenia
• patients in acute psychosis, severe symptoms of productive,
• patients taking clozapine,
• declaring suicidal tendencies, history of committing suicide in the past year.
• Associated with other psychiatric disorders
• patients currently meeting criteria for ICD-10 diagnosis of mental disorder other than schizophrenia (in the last 6 months before the visit of a selection), confirmed by the MINI questionnaire
• patients showing a prevalent and / or severe symptoms of depression (even without meeting criteria for major depressive episode according to ICD-10 criteria),

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Central Clinical Hospital

Lodz, Czechosłowacka 8/10, 92-216, Poland

Location

Related Publications (21)

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• Strzelecki D, Podgorski M, Kaluzynska O, Stefanczyk L, Kotlicka-Antczak M, Gmitrowicz A, Grzelak P. Adding Sarcosine to Antipsychotic Treatment in Patients with Stable Schizophrenia Changes the Concentrations of Neuronal and Glial Metabolites in the Left Dorsolateral Prefrontal Cortex. Int J Mol Sci. 2015 Oct 15;16(10):24475-89. doi: 10.3390/ijms161024475.

  PMID: 26501260 DERIVED

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  PMID: 26306650 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Sarcosine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

N-substituted Glycines; Glycine; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Dominik Strzelecki, MD, PhD

  Department of Affective and Psychotic Disorders, Medical University of Lodz

  PRINCIPAL INVESTIGATOR

• Jolanta Rabe-Jabłońska, MD, PhD

  Department of Affective and Psychotic Disorders, Medical University of Lodz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2011
• First Posted: January 4, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: January 1, 2016
• Last Updated: September 16, 2016

Record last verified: 2016-09

Locations

PL (1)