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OpenTrials
Completed

NCT Number: NCT01031927

N-methyl Glycine (Sarcosine) for the Treatment of Obsessive Compulsive Disorder (OCD)

Several lines of evidence implicate glutamatergic dysfunction in the pathophysiology of obsessive compulsive disorder (OCD). Sarcosine, also known as N-methylglycine, is an endogenous antagonist of glycine transporter-I (GlyT-I), which potentiates glycine's action at the glycine site of N-methyl-D-aspartate (NMDA) receptors. In this 10-week open-label trial, we examined the efficacy and safety of sarcosine treatment in OCD patients.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

China Medical University Hospital

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • a primary OCD according to DSM-IV
  • at least 1 year's duration of OC symptoms and a minimum severity score of ≥16 on Yale-Brown Obsessive Compulsive Scale
  • drug naïve at study entry or
  • being free from psychotropic medication for at least 8 weeks at study entry,or
  • inadequately responded to ongoing psychotropic medications at study entry (defined by a Y-BOCS score of ≧16 despite treatment with maximum tolerated dose of a SRI medication for at least 8 weeks)

Exclusion criteria

  • patients with moderate to severe depression defined by a 21-item Hamilton Depression Rating Scale score of >17,
  • a history of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychosis as defined by DSM-IV, or if they were at significant risk of suicide, and
  • with clinically significant organic disease including cardiovascular, hepatic, pulmonary, neurologic, metabolic, or renal disease

Treatment and study plan

N-methyl glycine

Drug

staring from 500mg/day, increased by 500mg biweekly, up to maximin of 2000mg/day

Other names: sarcosine

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Scale

    Time frame: week0, 2, 4, 6, 8, and 10

Secondary outcomes

  1. Hamilton Anxiety Rating scale

    Time frame: week0, 2, 4, 6, 8, and 10

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • Taipei City Hospital

Registry information

Official study title

Sarcosine as Primary or Adjunctive Therapy in Obsessive Compulsive Disorder: A Prospective, Open-label Study

Important dates

Study start
2007
Primary completion
2009
First posted
Dec 15, 2009
Registry last updated
Dec 29, 2009

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.

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