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

C

China Medical University

Status and phase

Completed
Phase 2

Conditions

Obsessive Compulsive Disorder

Treatments

Drug: N-methyl glycine

Study type

Interventional

Funder types

Other

Identifiers

NCT01031927
DMR96-IRB-75

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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