N-methylglycine (Sarcosine) Treatment for Depression

NCT00977353 | Completed Phase 2 DMC

• 1 other identifier: DOH95-TD-B-111-TM002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Depression; Major Depression

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 (4)

• dropout rate

  week 0, 2, 4, 6

• CGI(clinical global impression)

  week 0, 2, 4,6

• Response Rate

  Week 0, 2, 4, 6

• Factors of 17-item Hamilton Depression Rating Scale

  Week 0, 2, 4, 6

Study Arms (2)

sarcosine

EXPERIMENTAL

sarcosine

Drug: sarcosine

citalopram

ACTIVE COMPARATOR

citalopram

Drug: citalopram

Interventions

citalopram DRUG

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

citalopram

sarcosine DRUG

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

sarcosine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 34510411 DERIVED

• 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.

  PMID: 23562005 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Citalopram; Sarcosine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; N-substituted Glycines; Glycine; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 15, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 12, 2011

Record last verified: 2011-07

Locations

TW (1)