N-methylglycine (Sarcosine) Treatment for Depression - Full Text View

Sponsor:	China Medical University Hospital
Collaborator:	National Science Council, Taiwan
Information provided by:	China Medical University Hospital
ClinicalTrials.gov Identifier:	NCT00977353

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 II

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

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Sarcosine Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977353

Locations

Taiwan
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan

Sponsors and Collaborators

China Medical University Hospital

National Science Council, Taiwan

Investigators

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 February 09, 2012