Cognitive ImpairmentNCT04803071
Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression
A study testing Experimental group of n-pufas improving cognitive formula in people with Cognitive Impairment and Depression, run by Guangzhou Psychiatric Hospital at 1 site in China.
Trial summary
The aim of this study was to evaluate the effect of n-3pufas on cognitive function in patients with depression Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Depression
- What is being tested?
- Experimental group of n-pufas improving cognitive formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Oct 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria:① the patients met the diagnostic criteria of dsm-5 major depressive disorder; ② aged 18-55 years; ③ Hamilton Depression Scale score of 24 items ≥ 20 points; YMRS score < 6 points; ④ the score of wms-ii spatial span (assessment of working memory) in MCCB tool was less than or equal to its mean half standard deviation; ⑤ antidepressant types had not been adjusted in recent 2 weeks; 6) right handedness; 7) primary school had no change in the types of antidepressants The patients or their family members are willing to participate in the study and sign the informed consent.
Exclusion Criteria:① Merge with any other mental disorder; ② Patients with history of brain organic disease or traumatic brain injury and physical diseases; ③ abusers of drugs, alcohol or other psychoactive substances; ④ pregnant, lactating women and postpartum women; ⑤ refractory depression; ⑥ severe suicide risk (c-ssrs assessment); ⑦ MECT treatment in recent three months; ③ continuous use of diazepam drugs in recent three months; Ⅸ long-term use of npufas in recent three months; ⑩ Long term use of anti-inflammatory drugs in the past three months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
Guanzhou, Guangdong, 510370
Kangguang Lin, MD，PhD, 13560360144, klin@connect.hku.hk
About this study
Official title: Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression: a 12 Week Randomized, Double-blind, Placebo-controlled Study
The aim of this study was to evaluate the effect of n-3pufas on cognitive function in patients with depression
Read the detailed description
Depression is often accompanied by cognitive impairment. At present, there is no effective drug to improve the cognitive impairment in patients with depression, and the social function and quality of life of patients are affected in varying degrees. N-3 polyunsaturated fatty acids (n-3pufas) are food products with high safety and few adverse reactions. Previous clinical trials have also suggested that n-3pufas may help to improve cognitive impairment in patients with depression, but the reported results are different. We have developed a new generation of n-3pufas optimal proportion combination products and found good cognitive improvement effect in animal models of depression. Therefore, this clinical research project will screen out the depressive patients with cognitive impairment through the cognitive function battery test (MCCB) tool for schizophrenia. On the basis of routine treatment of depression, these patients will be added with the cognitive improvement formula n-3pufas capsule developed by us to explore the effect of n-3pufas formula on cognitive impairment of depression.
- Conditions
- Cognitive Impairment, Depression
- Being tested
- Experimental group of n-pufas improving cognitive formula, General fish oil formula product adjuvant treatment control group, Placebo assisted treatment group
- Medical subject headings
- Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group of n-pufas improving cognitive formulaDietary supplement
Three times a day, one capsule of n-3pufas improvement cognitive formula capsule (once in the morning, in the evening) and routine treatment for depression, lasting for 12 weeks
General fish oil formula product adjuvant treatment control groupDietary supplement
The control group: 1 capsule of general fish oil formula (once in the morning, in the evening) three times a day, plus routine treatment for depression, lasting for 12 weeks
Placebo assisted treatment groupDietary supplement
Three times a day, one capsule of placebo adjuvant therapy (once in the morning, one in the evening) and conventional treatment of depression for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant therapy trial group | Experimental | N-3pufas improved cognitive formula adjuvant therapy intervention group Receives: Dietary Supplement: Experimental group of n-pufas improving cognitive formula |
| Adjuvant treatment control group | Active comparator | General fish oil formula product adjuvant treatment control group Receives: Dietary Supplement: General fish oil formula product adjuvant treatment control group |
| Placebo assisted treatment control group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo assisted treatment group |
| Healthy group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
General information
Including gender, age, nationality, marriage, occupation, education level, education years, physical history, drug allergy history, tobacco and alcohol use.
Measured: At baseline
Clinical data
Including the age of the first onset, the total course of disease, the course of the disease, the number of attacks, past medical history, family history, suicide and self injury.
Measured: At baseline
Cognitive function assessment
Six cognitive dimensions, including processing speed, attention, working memory, language learning and memory, visual learning and memory, and executive function, were assessed by using standardized set of computer cognitive test (MCCB) based on MCCB, together with TONI-3 and tower of London (tower of London).
Measured: At baseline, at the end of the 4th, 8th and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Oct 2020
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Psychiatric Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kangguang Lin, Guangzhou Psychiatric Hospital
- Investigators
- kangguang Lin, PHD,MD, Principal investigator, Guangzhou Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803071
- Sponsor's protocol ID
- guangzhou brain ω-3
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression: a 12 Week Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04803071
- Acronym / sponsor ID
- guangzhou brain ω-3
- Conditions
- Cognitive Impairment, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Guangzhou Psychiatric HospitalOther government
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 17 Mar 2021 (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.
The aim of this study was to evaluate the effect of n-3pufas on cognitive function in patients with depression
Detailed description
Depression is often accompanied by cognitive impairment. At present, there is no effective drug to improve the cognitive impairment in patients with depression, and the social function and quality of life of patients are affected in varying degrees. N-3 polyunsaturated fatty acids (n-3pufas) are food products with high safety and few adverse reactions. Previous clinical trials have also suggested that n-3pufas may help to improve cognitive impairment in patients with depression, but the reported results are different. We have developed a new generation of n-3pufas optimal proportion combination products and found good cognitive improvement effect in animal models of depression. Therefore, this clinical research project will screen out the depressive patients with cognitive impairment through the cognitive function battery test (MCCB) tool for schizophrenia. On the basis of routine treatment of depression, these patients will be added with the cognitive improvement formula n-3pufas capsule developed by us to explore the effect of n-3pufas formula on cognitive impairment of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adjuvant therapy trial group | Experimental | Dietary Supplement: Experimental group of n-pufas improving cognitive formulaN-3pufas improved cognitive formula adjuvant therapy intervention group |
| Adjuvant treatment control group | Active comparator | Dietary Supplement: General fish oil formula product adjuvant treatment control groupGeneral fish oil formula product adjuvant treatment control group |
| Placebo assisted treatment control group | Placebo comparator | Dietary Supplement: Placebo assisted treatment group |
| Healthy group | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Experimental group of n-pufas improving cognitive formulaThree times a day, one capsule of n-3pufas improvement cognitive formula capsule (once in the morning, in the evening) and routine treatment for depression, lasting for 12 weeks | Dietary supplement | Adjuvant therapy trial group |
| General fish oil formula product adjuvant treatment control groupThe control group: 1 capsule of general fish oil formula (once in the morning, in the evening) three times a day, plus routine treatment for depression, lasting for 12 weeks | Dietary supplement | Adjuvant treatment control group |
| Placebo assisted treatment groupThree times a day, one capsule of placebo adjuvant therapy (once in the morning, one in the evening) and conventional treatment of depression for 12 weeks | Dietary supplement | Placebo assisted treatment control group |
Primary outcome
General information
Time frame: At baseline
Including gender, age, nationality, marriage, occupation, education level, education years, physical history, drug allergy history, tobacco and alcohol use.
Clinical data
Time frame: At baseline
Including the age of the first onset, the total course of disease, the course of the disease, the number of attacks, past medical history, family history, suicide and self injury.
Cognitive function assessment
Time frame: At baseline, at the end of the 4th, 8th and 12th week
Six cognitive dimensions, including processing speed, attention, working memory, language learning and memory, visual learning and memory, and executive function, were assessed by using standardized set of computer cognitive test (MCCB) based on MCCB, together with TONI-3 and tower of London (tower of London).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
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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.
kangguang Lin, PHD,MD principal investigator
Guangzhou Psychiatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group of n-pufas improving cognitive formula in people with Cognitive Impairment and Depression, run by Guangzhou Psychiatric Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Mar 2021. 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 China. 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.
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 Lin kangguang, PHD,MD (86-02081268189, klin@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General information (time frame: At baseline). 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?
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 17 Mar 2021.