Major Depressive DisorderNCT04156425
The Role of PKC Activation in the Immune-inflammatory Mechanism of Major Depressive Depression
A study testing Escitalopram+golimumab, Escitalopram+Calcium Tablet and Escitalopram in people with Major Depressive Disorder, run by Shanghai Mental Health Center.
Trial summary
Major Depressive disorder (MDD) is a heterogeneous mental illness. Treated with antidepressants that act on the neurotransmitter and/or their receptors just remitted only one third of patients with MDD, Thus, to improve the efficacy is a major unmet need for depression. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram+golimumab, Escitalopram+Calcium Tablet and Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 31 Dec 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men or women of matched age, gender and education with that of treatment-resistant depression (TRD) group;
- A willingness to adhere to all prohibitions and restrictions necessary for the study;
- Signed informed consent.
Who cannot join
- Participant who have severe mental diseases, physical diseases, cerebrovascular disease, or a history of traumatic brain injury;
- Participant who had a serious allergic reaction disease or those who have suffered from diseases of the immune system;
- Participant who used anti-inflammatory drugs, or immunomodulatory drugs no more than 1 month prior randomization;
- Pregnant or lactating female.
Trial locations and contacts
No sites are listed yet.
About this study
Major Depressive disorder (MDD) is a heterogeneous mental illness. Treated with antidepressants that act on the neurotransmitter and/or their receptors just remitted only one third of patients with MDD, Thus, to improve the efficacy is a major unmet need for depression. Based on the scientific reports, inflammation plays a definite role in the development and treatment of depression, which may be an important way to understand and finally solve the problem. Our team found that there were significant changes in tumor necrosis factor (TNF)-α and other inflammatory factors in depressed patients, which caused neuronal apoptosis and depressive symptoms; PRKCB1(gene of protein kinase C-β) plays an anti-inflammatory role by regulating protein kinase C(PKC) activation in specific brain region, improving neuroplasticity and playing an antidepressant role. In this study, we assumes that the treatment-resistant depression patients maybe due to the immune inflammation and PKC activation inconsistency or unsynchronized, which couldn't reversible microglia polarization and neuronal apoptosis in specific brain regions, then, caused the significant changes at emotional and cognitive neural circuits, so as to exhibit such as emotional, cognitive symptoms of depression. Therefore, activating PKC and regulating immune/inflammatory process will be another way to improve the treatment outcome of depression. Take consideration, we focus on treatment-resistant depression patients, to validate the relationship between PKC activation and the immune inflammatory mechanism of depression, evaluate the antidepressant effect of golimumab or calcium tablet (a PKC activator) plus escitalopram, and initially proposes idividualized treatment strategies for MDD.
Read the detailed description
This is a randomized, double blind, placebo-controlled antidepressant augmentation trial. All participants are randomly divided into 3 groups treated orally with "escitalopram + golimumab" (N = 60), "escitalopram + calcium tablet" (N = 60) or "escitalopram +placebo" (N = 60).
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram+golimumab, Escitalopram+Calcium Tablet, Escitalopram
- Keywords
- Major Depressive Disorder, neuroimmunology, Protein Kinase C
- 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.
Escitalopram+golimumabDrug
Also called Lexapro+Simponi
Escitalopram will be administered at 10-20 mg/d during the acute phase. Golimumab will be administered at the dose of 50mg every month during the acute phase.
Escitalopram+Calcium TabletDietary supplement
Also called Lexapro+Caltrate
Escitalopram will be administered at 10-20 mg/d during the acute phase. Calcium tablet will be administered at 2000mg/d during the acute phase.
EscitalopramDrug
Also called Lexapro
Escitalopram will be administered at 10-20 mg/d during the acute phase.
| Study group | Role | What they receive |
|---|---|---|
| escitalopram + golimumab | Experimental | Patients will be treated with escitalopram from the minimum dosage and golimumab according to direction for use. Receives: Drug: Escitalopram+golimumab |
| escitalopram + calcium tablet | Experimental | Patients will be treated with escitalopram from the minimum dosage and calcium tablet according to direction for use. Receives: Dietary Supplement: Escitalopram+Calcium Tablet |
| escitalopram | Active comparator | Patients will be treated with escitalopram from the minimum dosage. Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
remission of acute phase
scored 7 or lower on the Hamilton's Depression Scale with 17 items
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group1：escitalopram + golimumab (N = 60), group2：escitalopram + calcium tablet (N = 60) group3：escitalopram +placebo (N = 60).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yiru Fang, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156425
- Sponsor's protocol ID
- 81930033
- Status last verified
- Oct 2019
- First submitted
- 29 Oct 2019
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo X, Mao R, Cui L, Wang F, Zhou R, Wang Y, Huang J, Zhu Y, Yao Y, Zhao G, Li Z, Chen J, Wang J, Fang Y. PAID study design on the role of PKC activation in immune/inflammation-related depression: a randomised placebo-controlled trial protocol. Gen Psychiatr. 2021 Apr 5;34(2):e100440. doi: 10.1136/gpsych-2020-100440. eCollection 2021.
PubMed 33912799
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of PKC Activation in the Immune-inflammatory Mechanism of Major Depressive Depression
- ClinicalTrials.gov ID
- NCT04156425
- Acronym / sponsor ID
- 81930033
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, neuroimmunology, Protein Kinase C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Nov 2019 (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 heterogeneous mental illness. Treated with antidepressants that act on the neurotransmitter and/or their receptors just remitted only one third of patients with MDD, Thus, to improve the efficacy is a major unmet need for depression. Based on the scientific reports, inflammation plays a definite role in the development and treatment of depression, which may be an important way to understand and finally solve the problem. Our team found that there were significant changes in tumor necrosis factor (TNF)-α and other inflammatory factors in depressed patients, which caused neuronal apoptosis and depressive symptoms; PRKCB1(gene of protein kinase C-β) plays an anti-inflammatory role by regulating protein kinase C(PKC) activation in specific brain region, improving neuroplasticity and playing an antidepressant role. In this study, we assumes that the treatment-resistant depression patients maybe due to the immune inflammation and PKC activation inconsistency or unsynchronized, which couldn't reversible microglia polarization and neuronal apoptosis in specific brain regions, then, caused the significant changes at emotional and cognitive neural circuits, so as to exhibit such as emotional, cognitive symptoms of depression. Therefore, activating PKC and regulating immune/inflammatory process will be another way to improve the treatment outcome of depression. Take consideration, we focus on treatment-resistant depression patients, to validate the relationship between PKC activation and the immune inflammatory mechanism of depression, evaluate the antidepressant effect of golimumab or calcium tablet (a PKC activator) plus escitalopram, and initially proposes idividualized treatment strategies for MDD.
Detailed description
This is a randomized, double blind, placebo-controlled antidepressant augmentation trial. All participants are randomly divided into 3 groups treated orally with "escitalopram + golimumab" (N = 60), "escitalopram + calcium tablet" (N = 60) or "escitalopram +placebo" (N = 60).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- group1：escitalopram + golimumab (N = 60), group2：escitalopram + calcium tablet (N = 60) group3：escitalopram +placebo (N = 60).
| Arm | Type | Receives |
|---|---|---|
| escitalopram + golimumab | Experimental | Drug: Escitalopram+golimumabPatients will be treated with escitalopram from the minimum dosage and golimumab according to direction for use. |
| escitalopram + calcium tablet | Experimental | Dietary Supplement: Escitalopram+Calcium TabletPatients will be treated with escitalopram from the minimum dosage and calcium tablet according to direction for use. |
| escitalopram | Active comparator | Drug: EscitalopramPatients will be treated with escitalopram from the minimum dosage. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy men or women of matched age, gender and education with that of treatment-resistant depression (TRD) group;
- A willingness to adhere to all prohibitions and restrictions necessary for the study;
- Signed informed consent.
Key exclusion criteria (4 listed)
- Participant who have severe mental diseases, physical diseases, cerebrovascular disease, or a history of traumatic brain injury;
- Participant who had a serious allergic reaction disease or those who have suffered from diseases of the immune system;
- Participant who used anti-inflammatory drugs, or immunomodulatory drugs no more than 1 month prior randomization;
- Pregnant or lactating female.
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 |
|---|---|---|
| Escitalopram+golimumabAlso: Lexapro+SimponiEscitalopram will be administered at 10-20 mg/d during the acute phase. Golimumab will be administered at the dose of 50mg every month during the acute phase. | Drug | escitalopram + golimumab |
| Escitalopram+Calcium TabletAlso: Lexapro+CaltrateEscitalopram will be administered at 10-20 mg/d during the acute phase. Calcium tablet will be administered at 2000mg/d during the acute phase. | Dietary supplement | escitalopram + calcium tablet |
| EscitalopramAlso: LexaproEscitalopram will be administered at 10-20 mg/d during the acute phase. | Drug | escitalopram |
Primary outcome
remission of acute phase
Time frame: 12th week
scored 7 or lower on the Hamilton's Depression Scale with 17 items
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 33912799Guo X, Mao R, Cui L, Wang F, Zhou R, Wang Y, Huang J, Zhu Y, Yao Y, Zhao G, Li Z, Chen J, Wang J, Fang Y. PAID study design on the role of PKC activation in immune/inflammation-related depression: a randomised placebo-controlled trial protocol. Gen Psychiatr. 2021 Apr 5;34(2):e100440. doi: 10.1136/gpsych-2020-100440. eCollection 2021.
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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.
Yiru Fang study chair
Shanghai Mental Health Center
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram+golimumab, Escitalopram+Calcium Tablet and Escitalopram in people with Major Depressive Disorder, run by Shanghai Mental Health Center.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yiru Fang, MD. PhD. (021-64387250, yirufang@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remission of acute phase (time frame: 12th week). 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 NCT04156425, 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 12 May 2020.