N-methylglycine (Sarcosine) Treatment for Depression

Study Overview
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Brief Summary
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Major depressive disorder is a complex disease and most currently available antidepressants aiming at monoamine neurotransmission exhibit limited efficacy and cognitive effects. N-methyl-D-aspartate (NMDA), one subtype of glutamate receptors, plays an important role in learning and memory. N-methyl-D-aspartic acid (NMDA) enhancing agents, such as sarcosine (N-methylglycine), have been used as adjunctive therapy of schizophrenia. Sarcosine improved not only psychotic but also depressive symptoms in patients with schizophrenia. To confirm its antidepressant effect, the purpose of this study is to compare citalopram and sarcosine in efficacy for major depressive patients.

Detailed Description
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Major depressive disorder is a complex disease and most currently available antidepressants aiming at monoamine neurotransmission exhibit limited efficacy and cognitive effects. Novel therapies via manipulating other neurotransmission (e.g. glutamate receptor) are being developed. NMDA enhancing agents, such as sarcosine have been demonstrated to improve negative symptoms and depressive symptoms of schizophrenic patients. The purpose of this study is to compare citalopram and sarcosine in aspects of efficacy, safety in major depressive patients. In the study, 40 major depressive patients are recruited into the 6-week trial and randomly assigned into the two groups (20-60 mg/d citalopram, or 500 - 1500 mg/d sarcosine) with a double-blind manner. Hamilton Depression Rating Scale(17-item), CGI(Clinical Global Impression), GAF(Global Assessment of Function)and side effects are evaluated every two weeks during the trial. The efficacies of two groups are compared.

Official Title
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N-methylglycine (Sarcosine) for Treatment of Major Depressive Disorder

Conditions
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Major Depressive Disorder, Depression, Major Depression

Intervention / Treatment
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* Drug: citalopram
* Drug: sarcosine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-55 years Fulfilled the DSM-IV criteria of major depressive disorder Had a 17-item Hamilton Rating Scale for Depression (HAMD-17)>or= 18 No DSM-IV diagnosis of substance abuse or dependence (including alcohol) within the past 6 months Had been drug free for > 3 months Physically healthy and had all laboratory parameters within normal limits. Agree to participate in the study and provide informed consent Exclusion Criteria: Had history of epilepsy, head trauma or other major neurological or medical diseases Had psychotic depression, bipolar I/II disorder, schizophrenia or any other psychotic disorder Moderate-severe suicidal risks Severe cognitive impairment Female subjects who were pregnant, or at risk of pregnancy or lactation Initiating or stopping formal psychotherapy within six weeks prior to enrollment Had a history of poor response to SSRIs or previously received electroconvulsive therapy Had a history of severe adverse reaction to SSRIs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sarcosine<br>sarcosine | Drug: sarcosine<br>* 500-1500 mg/day, oral, for 6 weeks<br>|
| Active Comparator: citalopram<br>citalopram | Drug: citalopram<br>* 20-60 mg/day, oral, for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 17-item Hamilton Depression Rating Scale | score change | week 0, 2, 4, 6 | 
| Remission rate |  | week 0, 2,4, 6 | 
| GAF(Global Assessment of Function) | score changes | Week 0, 2, 4, 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dropout rate |  | week 0, 2, 4, 6 | 
| CGI(clinical global impression) | score changes | week 0, 2, 4,6 | 
| Response Rate |  | Week 0, 2, 4, 6 | 
| Factors of 17-item Hamilton Depression Rating Scale |  | Week 0, 2, 4, 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depressive disorder, Depression, Sarcosine, N-methylglycine, NMDA