N-methylglycine (Sarcosine) Treatment for Depression

China Medical University

Status and phase

Completed

Phase 2

Conditions

Major Depressive Disorder

Major Depression

Depression

Treatments

Drug: citalopram

Drug: sarcosine

Study type

Interventional

Funder types

Other

Identifiers

NCT00977353

DOH95-TD-B-111-TM002

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.