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N-methylglycine (Sarcosine) Treatment for Depression

Primary Purpose

Major Depressive Disorder, Depression, Major Depression

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

citalopram

sarcosine

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, Depression, Sarcosine, N-methylglycine, NMDA

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Psychiatry, China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sarcosine

citalopram

Arm Description

sarcosine

citalopram

Outcomes

Primary Outcome Measures

17-item Hamilton Depression Rating Scale

score change

Remission rate

GAF(Global Assessment of Function)

score changes

Secondary Outcome Measures

dropout rate

CGI(clinical global impression)

score changes

Response Rate

Factors of 17-item Hamilton Depression Rating Scale

Full Information

NCT ID

NCT00977353

First Posted

September 11, 2009

Last Updated

July 10, 2011

Sponsor

China Medical University Hospital

Collaborators

National Science Council, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT00977353

Brief Title

N-methylglycine (Sarcosine) Treatment for Depression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

China Medical University Hospital

Collaborators

National Science Council, Taiwan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder, Depression, Major Depression

Keywords

Major depressive disorder, Depression, Sarcosine, N-methylglycine, NMDA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sarcosine

Arm Type

Experimental

Arm Description

sarcosine

Arm Title

citalopram

Arm Type

Active Comparator

Arm Description

citalopram

Intervention Type

Drug

Intervention Name(s)

citalopram

Intervention Description

20-60 mg/day, oral, for 6 weeks

Intervention Type

Drug

Intervention Name(s)

sarcosine

Intervention Description

500-1500 mg/day, oral, for 6 weeks

Primary Outcome Measure Information:

Title

17-item Hamilton Depression Rating Scale

Description

score change

Time Frame

week 0, 2, 4, 6

Title

Remission rate

Time Frame

week 0, 2,4, 6

Title

GAF(Global Assessment of Function)

Description

score changes

Time Frame

Week 0, 2, 4, 6

Secondary Outcome Measure Information:

Title

dropout rate

Time Frame

week 0, 2, 4, 6

Title

CGI(clinical global impression)

Description

score changes

Time Frame

week 0, 2, 4,6

Title

Response Rate

Time Frame

Week 0, 2, 4, 6

Title

Factors of 17-item Hamilton Depression Rating Scale

Time Frame

Week 0, 2, 4, 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hsien-Yuan Lane, M.D., Ph.D

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chieh-Liang Huang, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Psychiatry, China Medical University Hospital

City

Taichung

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

34510411

Citation

Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.

Results Reference

derived

PubMed Identifier

23562005

Citation

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.

Results Reference

derived

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N-methylglycine (Sarcosine) Treatment for Depression

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