Depressive Disorder, MajorPhase 2NCT03414931
NMDA Modulation in Major Depressive Disorder in Late- Life
A Phase 2 study testing NMDA and Sertraline in people with Depressive Disorder, Major, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
Major depressive disorder (MDD) is a complex and multi-factorial disorder. Most of the current antidepressants are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- NMDA and Sertraline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2016to Nov 2020
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a DSM-IV (American Psychiatric Association 1994) diagnosis of MDD
- 17-item Hamilton Rating Scale for Depression total score ≥ 18
- Free of psychotropic drugs for at least 2 weeks
- Have a Mini-Mental State Examination (Folstein, Folstein et al. 1975) score ≥ 20
Who cannot join
- Current substance abuse or history of substance dependence in the past 6 months
- Use of depot antipsychotics in the past 6 months
- History of epilepsy, head trauma, stroke or other serious medical or neurological illness
- Bipolar depression, schizophrenia or other psychotic disorder
- Moderate-severe suicidal risks
- Severe cognitive impairment
Show all 11Show fewer
- Initiating or stopping formal psychotherapy within six weeks prior to enrollment
- A history of poor response to SSRIs or other antidepressants
- A history of previously received electroconvulsive therapy
- A history of severe adverse reaction to SSRIs or other antidepressants
- Inability to follow protocol
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Chang Gung Memorial Hospital
Kaohsiung City, 886
China Medical University Hospital
Taichung, 404
About this study
Major depressive disorder (MDD) is a complex and multi-factorial disorder. Most of the current antidepressants are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. Many elderly patients have significant side effects after treatment with antidepressants which hamper the motivation for treatment and medication adherence. NMDA hypofunction has been implicated in the pathophysiology of depression. MDD in the elderly is often associated with cognitive deficits which are not necessarily recovered by current antidepressants. The NMDA receptor regulates synaptic plasticity, memory, and cognition. In our previous studies, cognitive improvement has been observed with treatment of NMDA enhancers. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of NMDAE in the treatment of MDD in the elderly by comparing with sertraline (a selective serotonin reuptake inhibitor [SSRI]) and placebo.
The investigator will enroll elderly patients with MDD for an 8-week treatment. All patients will be randomly assigned into three groups: NMDAE, sertraline, or placebo. The investigator will biweekly measure clinical performances. Cognitive functions will be assessed at baseline and at endpoint of treatment by a battery of tests. The investigator hypothesize that NMDAE can safely yield better efficacy than placebo and sertraline for elderly patients with MDD.
- Conditions
- Depressive Disorder, Major
- Being tested
- NMDA, Sertraline, Placebo - Cap
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMDADrug
Also called NMDAE
Use of an NMDA enhancer for the treatment of MDD in late life
SertralineDrug
Use of SSRI as an active comparator
Placebo - CapDrug
Use of placebo as a comparator
| Study group | Role | What they receive |
|---|---|---|
| NMDAE | Experimental | An NMDA enhancer Receives: Drug: NMDA |
| SSRI | Active comparator | Sertraline Receives: Drug: Sertraline |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo - Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of 17-item Hamilton Rating Scale for Depression
Assessment of depressive symptoms. The 17-item Hamilton Rating Scale for Depression will be measured biweekly.
Measured: Week 0, 2, 4, 6, 8
Change from baseline of Perceived Stress Scale
Assessment of stress and anxiety symptoms. The Perceived Stress Scale will be measured biweekly
Measured: Week 0, 2, 4, 6, 8
Secondary outcomes (5)
Drop out rate
The rate of drop out
Measured: Week 0, 2, 4, 6, 8
Change from baseline of Geriatric Depression Scale
Assessment of geriatric depressive symptoms. The Geriatric Depression Scale will be measured biweekly
Measured: Week 0, 2, 4, 6, 8
Clinical Global Impression
Assessment of global improvement
Measured: Week 2, 4, 6, 8
Cognitive function
A battery of tests to assess the cognitive function including speed of processing (category fluency) and verbal and nonverbal working memory
Measured: Week 0, 8
Change from baseline of Beck's Suicide Scale
Assessment of suicidal symptoms. The Beck's Suicide Scale will be measured biweekly
Measured: Week 0, 2, 4, 6, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study startJan 2016
- Primary completionNov 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414931
- Sponsor's protocol ID
- 101-0365A3
- Status last verified
- Nov 2020
- First submitted
- 16 Jan 2018
- Last updated
- 1 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin CH, Wang SH, Lane HY. Effects of Sodium Benzoate, a D-Amino Acid Oxidase Inhibitor, on Perceived Stress and Cognitive Function Among Patients With Late-Life Depression: A Randomized, Double-Blind, Sertraline- and Placebo-Controlled Trial. Int J Neuropsychopharmacol. 2022 Aug 4;25(7):545-555. doi: 10.1093/ijnp/pyac006.
PubMed 35023557
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NMDA Modulation in Major Depressive Disorder in Late- Life
- ClinicalTrials.gov ID
- NCT03414931
- Acronym / sponsor ID
- 101-0365A3
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 30 Jan 2018 (actual)
- 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 (MDD) is a complex and multi-factorial disorder. Most of the current antidepressants are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. Many elderly patients have significant side effects after treatment with antidepressants which hamper the motivation for treatment and medication adherence. NMDA hypofunction has been implicated in the pathophysiology of depression. MDD in the elderly is often associated with cognitive deficits which are not necessarily recovered by current antidepressants. The NMDA receptor regulates synaptic plasticity, memory, and cognition. In our previous studies, cognitive improvement has been observed with treatment of NMDA enhancers. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of NMDAE in the treatment of MDD in the elderly by comparing with sertraline (a selective serotonin reuptake inhibitor [SSRI]) and placebo.
The investigator will enroll elderly patients with MDD for an 8-week treatment. All patients will be randomly assigned into three groups: NMDAE, sertraline, or placebo. The investigator will biweekly measure clinical performances. Cognitive functions will be assessed at baseline and at endpoint of treatment by a battery of tests. The investigator hypothesize that NMDAE can safely yield better efficacy than placebo and sertraline for elderly patients with MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMDAE | Experimental | Drug: NMDAAn NMDA enhancer |
| SSRI | Active comparator | Drug: SertralineSertraline |
| Placebo | Placebo comparator | Drug: Placebo - CapPlacebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a DSM-IV (American Psychiatric Association 1994) diagnosis of MDD
- 17-item Hamilton Rating Scale for Depression total score ≥ 18
- Free of psychotropic drugs for at least 2 weeks
- Have a Mini-Mental State Examination (Folstein, Folstein et al. 1975) score ≥ 20
Key exclusion criteria (11 listed)
- Current substance abuse or history of substance dependence in the past 6 months
- Use of depot antipsychotics in the past 6 months
- History of epilepsy, head trauma, stroke or other serious medical or neurological illness
- Bipolar depression, schizophrenia or other psychotic disorder
- Moderate-severe suicidal risks
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 |
|---|---|---|
| NMDAAlso: NMDAEUse of an NMDA enhancer for the treatment of MDD in late life | Drug | NMDAE |
| SertralineUse of SSRI as an active comparator | Drug | SSRI |
| Placebo - CapUse of placebo as a comparator | Drug | Placebo |
Primary outcome
Change from baseline of 17-item Hamilton Rating Scale for Depression
Time frame: Week 0, 2, 4, 6, 8
Assessment of depressive symptoms. The 17-item Hamilton Rating Scale for Depression will be measured biweekly.
Change from baseline of Perceived Stress Scale
Time frame: Week 0, 2, 4, 6, 8
Assessment of stress and anxiety symptoms. The Perceived Stress Scale will be measured biweekly
5 secondary outcomes
Drop out rate
Time frame: Week 0, 2, 4, 6, 8
Change from baseline of Geriatric Depression Scale
Time frame: Week 0, 2, 4, 6, 8
Clinical Global Impression
Time frame: Week 2, 4, 6, 8
Cognitive function
Time frame: Week 0, 8
Change from baseline of Beck's Suicide Scale
Time frame: Week 0, 2, 4, 6, 8
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 1 Dec 2020.
- Derived from this study: PubMed 35023557Lin CH, Wang SH, Lane HY. Effects of Sodium Benzoate, a D-Amino Acid Oxidase Inhibitor, on Perceived Stress and Cognitive Function Among Patients With Late-Life Depression: A Randomized, Double-Blind, Sertraline- and Placebo-Controlled Trial. Int J Neuropsychopharmacol. 2022 Aug 4;25(7):545-555. doi: 10.1093/ijnp/pyac006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NMDA and Sertraline in people with Depressive Disorder, Major, run by Chang Gung Memorial Hospital at 2 sites 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 4 inclusion and 11 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 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Change from baseline of 17-item Hamilton Rating Scale for Depression (time frame: Week 0, 2, 4, 6, 8). The study lists 2 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 NCT03414931, which also lists 1 linked publication.
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 1 Dec 2020.