Arachidonic acid supplementation for cognitive improvement in schizophrenia: a randomized controlled trial
| ISRCTN | ISRCTN17988045 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17988045 |
- Submission date
- 25/07/2025
- Registration date
- 28/07/2025
- Last edited
- 25/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Cognitive impairment associated with schizophrenia (CIAS) encompasses deficits in working memory, learning ability, and other core cognitive functions. Current antipsychotic treatments show limited efficacy in improving these symptoms. Arachidonic acid (AA), a key polyunsaturated fatty acid, plays crucial roles in neuronal membrane integrity and synaptic plasticity. Emerging evidence suggests AA deficiency may contribute to schizophrenia pathogenesis and cognitive dysfunction.
This randomized controlled trial aims to:
1. Investigate whether AA supplementation (350 mg/day) improves cognitive function in schizophrenia patients
2. Explore molecular mechanisms linking AA metabolism to cognitive enhancement
Who can participate?
Patients with SZ registered at the Suzhou Guangji Hospital, Jiangsu Province, China.
What does the study involve?
Participants will be randomly assigned (1:1) to AA group (350 mg AA daily + standard treatment) or Placebo group (Matching placebo + standard treatment)
Duration: 6 weeks
Assessments: Cognitive function (CANTAB battery) at baseline, 3 weeks, and 6 weeks; Blood samples for AA levels at baseline and endpoint; Safety monitoring throughout
What are the possible benefits and risks of participating?
Potential benefits:
• Improved cognitive performance
• Comprehensive health monitoring
• Free cognitive assessments
Potential risks:
• Psychological stress during testing
• Placebo group may not experience cognitive improvement
Where is the study run from?
1. Shanghai Jiao Tong University Bio-X Institute (China)
2. Suzhou Guangji Hospital (collaborating site) (China)
When is the study starting and how long is it expected to run for?
June 2025 to October 2025
Who is funding the study?
National Natural Science Foundation of China
Shanghai Jiao Tong University (China)
Who is the main contact?
Contact Principal Investigator: Chunling Wan, PhD Email: clwan@sjtu.edu.cn
Contact information
Principal Investigator
No. 1954, Huashan Road
Shanghai
200030
China
 ORCID ID |
0000-0002-0372-0041 |
|---|---|
| Phone | + 86 21 62833148 |
| clwan@sjtu.edu.cn |
Scientific, Principal Investigator
No. 1954, Huashan Road
Shanghai
200030
China
| Phone | + 86 21 62833148 |
|---|---|
| xiaowen@sjtu.edu.cn |
Public, Scientific
No. 1954, Huashan Road
Shanghai
200030
China
| Phone | +86 21 62833148 |
|---|---|
| Gao_Yan@sjtu.edu.cn |
Study information
| Study design | Single-center interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A randomized, double-blind, placebo-controlled trial of arachidonic acid (AA) supplementation for cognitive impairment in schizophrenia |
| Study objectives | To evaluate whether 6-week arachidonic acid (AA) supplementation improves cognitive function in schizophrenia patients, as measured by CANTAB neuropsychological tests. |
| Ethics approval(s) |
Approved 26/06/2025, Shanghai Jiao Tong University (800 Dongchuan Road, Minhang District, Shanghai, 20030, China; -; IRB.HRP@sjtu.edu.cn), ref: B20250551I |
| Health condition(s) or problem(s) studied | Schizophrenia |
| Intervention | This randomized, double-blind, placebo-controlled trial will compare arachidonic acid (AA) supplementation versus placebo in schizophrenia patients. Eligible participants will be randomly allocated 1:1 to either: 1. AA group: Oral administration of 350 mg AA once daily after breakfast for 6 weeks, alongside standard antipsychotic treatment. 2. Placebo group: Identical-appearing formulation containing fatty acids without AA, administered under the same regimen. Randomization will be performed using computer-generated sequences with concealed allocation. All participants will maintain their prescribed antipsychotics without dosage adjustments during the trial. Cognitive function assessed using CANTAB and blood AA levels will be assessed at baseline, 3 weeks, and 6 weeks. Adherence will be monitored through medication count and patient diaries |
| Intervention type | Supplement |
| Primary outcome measure | Cognitive function will be measured using the Cambridge Neuropsychological Test Automated Battery® (CANTAB®) system at baseline, week 3, and 6. |
| Secondary outcome measures | RBC's fatty acids will be measured using gas chromatography-mass spectrometry at baseline and week 6. |
| Overall study start date | 01/06/2025 |
| Completion date | 01/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 66 = 33 in AA group and 33 in AA-free placebo group |
| Key inclusion criteria | 1. Confirmed diagnosis of schizophrenia according to ICD-10 criteria 2. Willingness to participate, with signed informed consent from the patient or their legal guardian |
| Key exclusion criteria | 1.Patients should not have a history of other mental disorders, neurological disorders, serious physical diseases, traumatic brain injury, substance abuse, or dependence 2. Enrollment in another clinical trial within 4 weeks prior to screening 3. Pregnancy, lactation, or plans to conceive during the study |
| Date of first enrolment | 01/08/2025 |
| Date of final enrolment | 01/09/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Suzhou
215131
China
Sponsor information
University/education
No. 1954, Huashan Road
Shanghai
200030
China
| Phone | + 86 21 62833148 |
|---|---|
| avenkeven@hotmail.com | |
| Website | https://www.sjtu.edu.cn |
"ROR" |
https://ror.org/0220qvk04 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. |
Editorial Notes
25/07/2025: Trial's existence confirmed by Shanghai Jiao Tong University.
