N-methylglycine (Sarcosine) Treatment for Depression

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00977353
First received: September 11, 2009
Last updated: July 10, 2011
Last verified: July 2011
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by China Medical University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on September 29, 2014