Depression, Major Depression, Major Depressive Disorder
Conditions
Keywords
Major depressive disorder, Depression, Sarcosine, N-methylglycine, NMDA
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.
Interventions
DRUGcitalopram
20-60 mg/day, oral, for 6 weeks
DRUGsarcosine
500-1500 mg/day, oral, for 6 weeks
Sponsors
National Science and Technology Council, Taiwan
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| dropout rate | week 0, 2, 4, 6 | — |
| Factors of 17-item Hamilton Depression Rating Scale | Week 0, 2, 4, 6 | — |
| CGI(clinical global impression) | week 0, 2, 4,6 | score changes |
| Response Rate | Week 0, 2, 4, 6 | — |
Countries
Taiwan
Outcome results
None listed