N-methylglycine (Sarcosine) Treatment for Depression

Phase 2

Completed

• Conditions: Major Depressive Disorder; Depression; Major Depression
• Interventions: Drug: sarcosine; Drug: citalopram

• Registration Number: NCT00977353
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-14
• Study First Posted: 2009-09-15
• Status Verified: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-10
• Last Update Posted: 2011-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sarcosine	sarcosine	sarcosine
citalopram	citalopram	citalopram

Primary Outcome Measures

Name	Time	Method
17-item Hamilton Depression Rating Scale	week 0, 2, 4, 6	score change
Remission rate	week 0, 2,4, 6
GAF(Global Assessment of Function)	Week 0, 2, 4, 6	score changes

Secondary Outcome Measures

Name	Time	Method
Response Rate	Week 0, 2, 4, 6
Factors of 17-item Hamilton Depression Rating Scale	Week 0, 2, 4, 6
dropout rate	week 0, 2, 4, 6
CGI(clinical global impression)	week 0, 2, 4,6	score changes

Trial Locations

Locations (1)

Department of Psychiatry, China Medical University Hospital; 🇨🇳 Taichung, Taiwan