Major Depressive DisorderPhase 2NCT00977353
N-methylglycine (Sarcosine) Treatment for Depression
A Phase 2 study testing citalopram and sarcosine in people with Major Depressive Disorder and Depression, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder, Depression, Major Depression
- What is being tested?
- citalopram and sarcosine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2009to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Psychiatry, China Medical University Hospital
Taichung
About this study
Official title: N-methylglycine (Sarcosine) for Treatment of Major Depressive Disorder
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Depression, Major Depression
- Being tested
- citalopram, sarcosine
- Keywords
- Major depressive disorder, Depression, Sarcosine, N-methylglycine, NMDA
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citalopramDrug
20-60 mg/day, oral, for 6 weeks
sarcosineDrug
500-1500 mg/day, oral, for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| sarcosine | Experimental | sarcosine Receives: Drug: sarcosine |
| citalopram | Active comparator | citalopram Receives: Drug: citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-item Hamilton Depression Rating Scale
score change
Measured: week 0, 2, 4, 6
Remission rate
Measured: week 0, 2,4, 6
GAF(Global Assessment of Function)
score changes
Measured: Week 0, 2, 4, 6
Secondary outcomes (4)
dropout rate
Measured: week 0, 2, 4, 6
CGI(clinical global impression)
score changes
Measured: week 0, 2, 4,6
Response Rate
Measured: Week 0, 2, 4, 6
Factors of 17-item Hamilton Depression Rating Scale
Measured: Week 0, 2, 4, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Hsien-Yuan Lane, M.D., Ph.D, Principal investigator, Department of Psychiatry, China Medical University Hospital, Taichung, TaiwanChieh-Liang Huang, MD, Principal investigator, Department of Psychiatry, China Medical University Hospital,Taichung,Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977353
- Sponsor's protocol ID
- DOH95-TD-B-111-TM002
- Status last verified
- Jul 2011
- First submitted
- 11 Sep 2009
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
PubMed 34510411Huang CC, Wei IH, Huang CL, Chen KT, Tsai MH, Tsai P, Tun R, Huang KH, Chang YC, Lane HY, Tsai GE. Inhibition of glycine transporter-I as a novel mechanism for the treatment of depression. Biol Psychiatry. 2013 Nov 15;74(10):734-41. doi: 10.1016/j.biopsych.2013.02.020. Epub 2013 Apr 3.
PubMed 23562005
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-methylglycine (Sarcosine) for Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00977353
- Acronym / sponsor ID
- DOH95-TD-B-111-TM002
- Conditions
- Major Depressive Disorder, Depression, Major Depression
- Keywords
- Major depressive disorder, Depression, Sarcosine, N-methylglycine, NMDA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Apr 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sarcosine | Experimental | Drug: sarcosinesarcosine |
| citalopram | Active comparator | Drug: citalopramcitalopram |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| citalopram20-60 mg/day, oral, for 6 weeks | Drug | citalopram |
| sarcosine500-1500 mg/day, oral, for 6 weeks | Drug | sarcosine |
Primary outcome
17-item Hamilton Depression Rating Scale
Time frame: week 0, 2, 4, 6
score change
Remission rate
Time frame: week 0, 2,4, 6
GAF(Global Assessment of Function)
Time frame: Week 0, 2, 4, 6
score changes
4 secondary outcomes
dropout rate
Time frame: week 0, 2, 4, 6
CGI(clinical global impression)
Time frame: week 0, 2, 4,6
Response Rate
Time frame: Week 0, 2, 4, 6
Factors of 17-item Hamilton Depression Rating Scale
Time frame: Week 0, 2, 4, 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
- Derived from this study: PubMed 34510411Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
- Derived from this study: PubMed 23562005Huang CC, Wei IH, Huang CL, Chen KT, Tsai MH, Tsai P, Tun R, Huang KH, Chang YC, Lane HY, Tsai GE. Inhibition of glycine transporter-I as a novel mechanism for the treatment of depression. Biol Psychiatry. 2013 Nov 15;74(10):734-41. doi: 10.1016/j.biopsych.2013.02.020. Epub 2013 Apr 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsien-Yuan Lane, M.D., Ph.D principal investigator
Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan
Chieh-Liang Huang, MD principal investigator
Department of Psychiatry, China Medical University Hospital,Taichung,Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing citalopram and sarcosine in people with Major Depressive Disorder and Depression, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
17-item Hamilton Depression Rating Scale (time frame: week 0, 2, 4, 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00977353, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2011.