Schizophrenia Clinical Trial
— PULSAROfficial title:
Effect of Sarcosine on Symptomatology, Quality of Life, Cognitive and Sexual Functioning, Blood Levels of Sarcosine, Glycine, BDNF and MMP-9, Oculomotor, Brain Metabolism and Oxidative Stress Parameters in Schizophrenia.
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | January 2016 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: 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), - patients ever diagnosed with lifetime bipolar disorder, - patients with severe personality disorders, particularly type of antisocial, borderline, or histrionicznego that could affect the assessment of test results. Other - abuse or addiction to alcohol or psychoactive substances (excluding nicotine) within the last 6 months, according to the criteria of ICD-10, confirmed by the MINI questionnaire, - disturbances occurring in the form of somatic according to ICD-10 criteria, - Delirium or dementia according to ICD-10 criteria, - current diagnosis of neurological diseases (eg, stroke, seizures, migraine, multiple sclerosis), - liver failure (ie, cirrhosis or active liver disease), diagnosed acute or chronic hepatitis, - severe or uncontrolled somatic disease that could affect the course of the study (eg cancer, cardiovascular, respiratory, metabolic or oral, severe renal failure, unstable diabetes type I or II, morbid obesity, untreated or uncontrolled hypertension, clinically significant blood), - thyroid dysfunction (especially hypothyroidism) untreated or uncontrolled, T - thyroid hormones treatment started, terminated or modified in the 3 months before the selection visit, - hormone replacement therapy started, terminated or modified in the 3 months before the selection visit. - recognized disorders of hemostasis, Associated with a prior or concomitant treatment Particular caution should be maintained when using drugs likely to affect the central nervous system - their mechanism of action could affect the course of the study. Use of these substances after the selection visit is not allowed. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Poland | Central Clinical Hospital | Lódz | Czechoslowacka 8/10 |
Lead Sponsor | Collaborator |
---|---|
Medical Universtity of Lodz |
Poland,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of sarcosine vs. placebo impact on schizophrenia symptoms using Positive and Negative Syndrome Scale (PANSS). | Both arms, every visit | 6 months | No |
Secondary | Impact assessment of sarcosine versus placebo on the parameters of quality of life (QoL) and sexual functioning. | Both arms, every visit | 6 months | No |
Secondary | Impact assessment of sarcosine versus placebo on depressive symptoms using Calgary Depression Scale for Schizophrenia. | Both arms, every visit | 6 months | No |
Secondary | Impact assessment of sarcosine versus placebo on cognitive functions using Wisconsin Card Sort Test, Trail Making Test and Stroop Test. | Both arms, before and after taking sarcosine or placebo | 6 months | No |
Secondary | Impact assessment of sarcosine versus placebo on oxidative stress parameters (T-BARS). | Both arms, before and after taking sarcosine or placebo | 6 months | No |
Secondary | Impact assessment of sarcosine versus placebo on brain metabolism parameters (magnetic resonance spectroscopy). | Both arms, before and after taking sarcosine or placebo | 6 months | No |
Secondary | Impact assessment of sarcosine versus placebo on oculomotoric parameters (saccadic and antisaccadic task in electrooculography). | Both arms, before and after taking sarcosine or placebo | 6 months | No |
Secondary | Impact assessment of sarcosine versus placebo on blood levels of glycine, sarcosine, BDNF and MMP-9. | Both arms, before and after taking sarcosine or placebo | 6 months | No |
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