DepressionNCT05941754
A Clinical Study of Omega-3 on Depression and Cognition
A study testing omega-3 in people with Depression, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Depression is a serious mental illness, with persistent depression and loss of interest as the main clinical manifestations, and causes varying degrees of cognitive impairment, further leading to impaired social function, and even lead to suicidal behavior. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- current moderate to severe depressive episode (DSM-5)
- HAMD-17>16
- 18≤Age≤45
- Never use of fluoxetine and no use of any antipsychotic and antidepressant drugs and mood stablizer at least 8 weeks
- Current physical or laboratory tests show good health
- negative usrine drug tests
- voluntray to sign the consent form
Who cannot join
- treat-resistant depressive disorder
- other axis I/II dignoses
- MMSE≤27 recent abuse history of alcohol or drugs pregnant or breast breeding
Trial locations and contacts
1 site in 1 country.
About this study
Depression is a serious mental illness, with persistent depression and loss of interest as the main clinical manifestations, and causes varying degrees of cognitive impairment, further leading to impaired social function, and even lead to suicidal behavior. Previous studies on the antidepressant effects of Omega-3 mainly focused on chronic effects, and there was a lack of corresponding rapid response clinical studies. Because of the nature of Omega-3 health products, no clinical adverse effects have been reported. We have previously shown that Omega-3 can produce antidepressant and cognitive improvement effects. This study will carry out different doses (low dose and high dose) and single active ingredient (EPA alone) to observe the antidepressant and cognitive improvement effects of Omega-3 in clinical patients with major depression. The antidepressant effect and cognitive improvement effect of Omega-3 will be further verified to provide evidence for future clinical application.
- Conditions
- Depression
- Being tested
- omega-3, placebo
- Keywords
- omega-3, cognition, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3Dietary supplement
supplement in the market
placeboDietary supplement
corn oil
| Study group | Role | What they receive |
|---|---|---|
| high omega-3 group | Experimental | A single dose of 4.0g EPA was given orally Receives: Dietary Supplement: omega-3 |
| low omega-3 group | Experimental | A single dose of 2.0g EPA was given orally Receives: Dietary Supplement: omega-3 |
| placebo group | Placebo comparator | A single dose of 4.0g corn oil was given orally Receives: Dietary Supplement: placebo |
| healthy control group | No intervention | no intervention. assessement of cognitive performance twice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
depressive symptom
Hamilton Depression Scale (HAMD)-17, more reduaction mean better outcome
Measured: 40 minutes
Secondary outcomes (4)
Cognitive performance Working memory
Working memory: digit span test from the Wechsler Memory Scale-Third Edition (WMS-III)
Measured: 4 hours
Cognitive performance Verbal memory
Verbal memory: evaluate the Logical Memory including immediate/delayed recall and recognition from the WMS-III.
Measured: 4 hours
Cognitive performance Visual memory
Visual memory: Rey-Osterrieth Complex Figure (ROCF) task
Measured: 4 hours
Cognitive performance
executive function: the Stroop Test and the Wisconsin Card Sorting Test (WCST). more improvement mean better outcome
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start15 Dec 2022
- 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.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941754
- Sponsor's protocol ID
- NFEC-2023-051
- Status last verified
- Jul 2023
- First submitted
- 15 Feb 2023
- Last updated
- 12 Jul 2023
- 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 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Omega-3 on Depression and Cognition
- ClinicalTrials.gov ID
- NCT05941754
- Acronym / sponsor ID
- NFEC-2023-051
- Conditions
- Depression
- Keywords
- omega-3, cognition, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jul 2023 (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.
Depression is a serious mental illness, with persistent depression and loss of interest as the main clinical manifestations, and causes varying degrees of cognitive impairment, further leading to impaired social function, and even lead to suicidal behavior. Previous studies on the antidepressant effects of Omega-3 mainly focused on chronic effects, and there was a lack of corresponding rapid response clinical studies. Because of the nature of Omega-3 health products, no clinical adverse effects have been reported. We have previously shown that Omega-3 can produce antidepressant and cognitive improvement effects. This study will carry out different doses (low dose and high dose) and single active ingredient (EPA alone) to observe the antidepressant and cognitive improvement effects of Omega-3 in clinical patients with major depression. The antidepressant effect and cognitive improvement effect of Omega-3 will be further verified to provide evidence for future clinical application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| high omega-3 group | Experimental | Dietary Supplement: omega-3A single dose of 4.0g EPA was given orally |
| low omega-3 group | Experimental | Dietary Supplement: omega-3A single dose of 2.0g EPA was given orally |
| placebo group | Placebo comparator | Dietary Supplement: placeboA single dose of 4.0g corn oil was given orally |
| healthy control group | No intervention | –no intervention. assessement of cognitive performance twice. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- current moderate to severe depressive episode (DSM-5)
- HAMD-17>16
- 18≤Age≤45
- Never use of fluoxetine and no use of any antipsychotic and antidepressant drugs and mood stablizer at least 8 weeks
- Current physical or laboratory tests show good health
Key exclusion criteria (3 listed)
- treat-resistant depressive disorder
- other axis I/II dignoses
- MMSE≤27 recent abuse history of alcohol or drugs pregnant or breast breeding
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 |
|---|---|---|
| omega-3supplement in the market | Dietary supplement | high omega-3 group, low omega-3 group |
| placebocorn oil | Dietary supplement | placebo group |
Primary outcome
depressive symptom
Time frame: 40 minutes
Hamilton Depression Scale (HAMD)-17, more reduaction mean better outcome
4 secondary outcomes
Cognitive performance Working memory
Time frame: 4 hours
Cognitive performance Verbal memory
Time frame: 4 hours
Cognitive performance Visual memory
Time frame: 4 hours
Cognitive performance
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 in people with Depression, run by Nanfang Hospital, Southern Medical University 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?
The sponsor lists 7 inclusion and 3 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 Jul 2023. 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?
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?
depressive symptom (time frame: 40 minutes). 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 12 Jul 2023.