N-methylglycine (Sarcosine) Treatment for Depression
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder Depression Major Depression |
Drug: citalopram Drug: sarcosine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | N-methylglycine (Sarcosine) for Treatment of Major Depressive Disorder |
- 17-item Hamilton Depression Rating Scale [ Time Frame: week 0, 2, 4, 6 ] [ Designated as safety issue: No ]score change
- Remission rate [ Time Frame: week 0, 2,4, 6 ] [ Designated as safety issue: No ]
- GAF(Global Assessment of Function) [ Time Frame: Week 0, 2, 4, 6 ] [ Designated as safety issue: No ]score changes
- dropout rate [ Time Frame: week 0, 2, 4, 6 ] [ Designated as safety issue: No ]
- CGI(clinical global impression) [ Time Frame: week 0, 2, 4,6 ] [ Designated as safety issue: No ]score changes
- Response Rate [ Time Frame: Week 0, 2, 4, 6 ] [ Designated as safety issue: No ]
- Factors of 17-item Hamilton Depression Rating Scale [ Time Frame: Week 0, 2, 4, 6 ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | April 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: sarcosine
sarcosine
|
Drug: sarcosine
500-1500 mg/day, oral, for 6 weeks
Other Name: sarcosine
|
|
Active Comparator: citalopram
citalopram
|
Drug: citalopram
20-60 mg/day, oral, for 6 weeks
Other Name: citalopram
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Taiwan | |
| Department of Psychiatry, China Medical University Hospital | |
| Taichung, Taiwan | |
| Principal Investigator: | Hsien-Yuan Lane, M.D., Ph.D | Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan |
| Principal Investigator: | Chieh-Liang Huang, MD | Department of Psychiatry, China Medical University Hospital,Taichung,Taiwan |
More Information
No publications provided
| Responsible Party: | Hsien-Yuan Lane, M.D., Ph.D, Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan |
| ClinicalTrials.gov Identifier: | NCT00977353 History of Changes |
| Other Study ID Numbers: | DOH95-TD-B-111-TM002 |
| Study First Received: | September 11, 2009 |
| Last Updated: | July 10, 2011 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by China Medical University Hospital:
|
Major depressive disorder Depression Sarcosine N-methylglycine NMDA |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Citalopram Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 19, 2013