Skip to main content
OpenTrials
Completed

NCT Number: NCT00977353

N-methylglycine (Sarcosine) Treatment for Depression

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Citalopram

Drug

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

sarcosine

Drug

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

Primary outcomes

  1. 17-item Hamilton Depression Rating Scale

    Time frame: week 0, 2, 4, 6

    score change

  2. Remission rate

    Time frame: week 0, 2,4, 6

  3. GAF(Global Assessment of Function)

    Time frame: Week 0, 2, 4, 6

    score changes

Secondary outcomes

  1. dropout rate

    Time frame: week 0, 2, 4, 6

  2. CGI(clinical global impression)

    Time frame: week 0, 2, 4,6

    score changes

  3. Response Rate

    Time frame: Week 0, 2, 4, 6

  4. Factors of 17-item Hamilton Depression Rating Scale

    Time frame: Week 0, 2, 4, 6

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 15, 2009
Registry last updated
Jul 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.