N-methylglycine (Sarcosine) Treatment for Depression | NCT00977353

Studies
N-methylglycine (Sarcosine) Treatment for Depression

NCT00977353

Sponsor

China Medical University Hospital

Status

Completed

Last Update Posted

Jul 12, 2011Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Major Depressive Disorder
Depression
Major Depression

Interventions

citalopram
sarcosine

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Sep 11, 2009

First Submission Date that Met QC Criteria

Sep 14, 2009

First Posted Date

Sep 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2011

Last Update Posted Date

Jul 12, 2011Estimated

Name	Class
National Science and Technology Council, Taiwan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sarcosine	Experimental	sarcosine	Drug: sarcosine
citalopram	Active Comparator	citalopram	Drug: citalopram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
citalopram	Drug	20-60 mg/day, oral, for 6 weeks	citalopram
sarcosine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
17-item Hamilton Depression Rating Scale	score change	week 0, 2, 4, 6
Remission rate		week 0, 2,4, 6
GAF(Global Assessment of Function)	score changes	Week 0, 2, 4, 6

Secondary Outcomes

Measure	Description	Time Frame
dropout rate		week 0, 2, 4, 6
CGI(clinical global impression)	score changes	week 0, 2, 4,6
Response Rate

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Psychiatry, China Medical University Hospital		Taichung			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34510411	Derived	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.
23562005

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

ID	Term
D015283	Citalopram
D012521	Sarcosine

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572