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N-methylglycine (Sarcosine) Treatment for Depression

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ClinicalTrials.gov Identifier: NCT00977353
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : July 12, 2011
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
China Medical University Hospital

Tracking Information
First Submitted Date  ICMJE September 11, 2009
First Posted Date  ICMJE September 15, 2009
Last Update Posted Date July 12, 2011
Study Start Date  ICMJE April 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2011)
  • 17-item Hamilton Depression Rating Scale [ Time Frame: week 0, 2, 4, 6 ]
    score change
  • Remission rate [ Time Frame: week 0, 2,4, 6 ]
  • GAF(Global Assessment of Function) [ Time Frame: Week 0, 2, 4, 6 ]
    score changes
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
21-item Hamilton Depression Rating Scale [ Time Frame: week 0, 2, 4, 6 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2011)
  • dropout rate [ Time Frame: week 0, 2, 4, 6 ]
  • CGI(clinical global impression) [ Time Frame: week 0, 2, 4,6 ]
    score changes
  • Response Rate [ Time Frame: Week 0, 2, 4, 6 ]
  • Factors of 17-item Hamilton Depression Rating Scale [ Time Frame: Week 0, 2, 4, 6 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
Digit Span, Episodic Memory, Wisconsin Card Sorting Test [ Time Frame: week 0,6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE N-methylglycine (Sarcosine) Treatment for Depression
Official Title  ICMJE N-methylglycine (Sarcosine) for Treatment of Major Depressive Disorder
Brief Summary 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Depression
  • Major Depression
Intervention  ICMJE
  • Drug: citalopram
    20-60 mg/day, oral, for 6 weeks
  • Drug: sarcosine
    500-1500 mg/day, oral, for 6 weeks
Study Arms  ICMJE
  • Experimental: sarcosine
    sarcosine
    Intervention: Drug: sarcosine
  • Active Comparator: citalopram
    citalopram
    Intervention: Drug: citalopram
Publications * Huang CC, Wei IH, Huang CL, Chen KT, Tsai MH, Tsai P, Tun R, Huang KH, Chang YC, Lane HY, Tsai GE. Inhibition of glycine transporter-I as a novel mechanism for the treatment of depression. Biol Psychiatry. 2013 Nov 15;74(10):734-41. doi: 10.1016/j.biopsych.2013.02.020. Epub 2013 Apr 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2011)
40
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2009)
30
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00977353
Other Study ID Numbers  ICMJE DOH95-TD-B-111-TM002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hsien-Yuan Lane, M.D., Ph.D, Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan
Study Sponsor  ICMJE China Medical University Hospital
Collaborators  ICMJE National Science Council, Taiwan
Investigators  ICMJE
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
PRS Account China Medical University Hospital
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP