N-methylglycine (Sarcosine) Treatment for Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977353
• Other study ID #: DOH95-TD-B-111-TM002
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2009
• Last updated: July 10, 2011
• Start date: April 2009
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Major Depressive Disorder

Intervention

Drug:
• citalopram
20-60 mg/day, oral, for 6 weeks
• sarcosine
500-1500 mg/day, oral, for 6 weeks

Locations

Country	Name	City	State
Taiwan	Department of Psychiatry, China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	17-item Hamilton Depression Rating Scale	score change	week 0, 2, 4, 6	No
Primary	Remission rate		week 0, 2,4, 6	No
Primary	GAF(Global Assessment of Function)	score changes	Week 0, 2, 4, 6	No
Secondary	dropout rate		week 0, 2, 4, 6	No
Secondary	CGI(clinical global impression)	score changes	week 0, 2, 4,6	No
Secondary	Response Rate		Week 0, 2, 4, 6	No
Secondary	Factors of 17-item Hamilton Depression Rating Scale		Week 0, 2, 4, 6	No