Effects of ω-3 polyunsaturated fatty acid supplementation in the treatment of adolescents with depressive disorder
| ISRCTN | ISRCTN68038781 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68038781 |
- Submission date
- 23/02/2022
- Registration date
- 12/03/2022
- Last edited
- 30/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Depressive disorder (DD) has become a common recurrent disease among adolescents and the treatment of adolescent DD is inadequate and less effective. The rate of receiving treatment in adolescent depression is lower than that in adults, and antidepressants and psychotherapy that are effective in the treatment of depression in adults have a limited effect in adolescents. Therefore, there is an urgent need for safer and more effective treatments for adolescent depression. Several clinical trials have shown that the use of polyunsaturated fatty acids (PUFAs) is a safe and effective adjuvant therapy in adult DD but studies are very limited in adolescents. The aim of this study is to evaluate the effect of ω-3 PUFA extra supplementation in adolescent depression, and explore whether the niacin skin flushing response relates to depressive symptoms.
Who can participate?
Adolescents aged 14-25 years with depression who are registered at the Fourth People's Hospital of Wuhu
What does the study involve?
Patients are randomly allocated to one of two groups. Those in the first group only take the antidepressant paroxetine every day for 12 weeks. Those in the second group take three capsules of ω-3 PUFA rich fish oil per day for 12 weeks in addition to paroxetine treatment. The niacin skin flushing response and the severity of depressive symptoms, cognition, and memory conditions are assessed by trained psychiatrists before treatment and at weeks 4, 8, and 12. Blood samples are taken at weeks 0 and 12.
What are the possible benefits and risks of participating?
Participants who receive the PUFA may benefit from a reduction of their depressive symptoms. There are no known risks involved with participating.
Where is the study run from?
1. Shanghai Jiao Tong University (China)
2. The Fourth People's Hospital of Wuhu (China)
When is the study starting and how long is it expected to run for?
April 2020 to December 2025
Who is funding the study?
1. Health Commission of Anhui Province (China)
2. Natural Science Foundation of Shanghai (China)
3. Shanghai Jiao Tong University (China)
Who is the main contact?
Shuhui Li
230204199609291726@sjtu.edu.cn
Contact information
Principal Investigator
No. 1954, Huashan Road
Shanghai
200030
China
 ORCID ID |
0000-0001-5846-9248 |
|---|---|
| Phone | +86 (0)21 62932779 |
| qingying@sjtu.edu.cn |
Scientific
No. 1954, Huashan Road
Shanghai
200030
China
| ORCID ID |
0000-0002-3120-495X |
|---|---|
| Phone | +86 (0)5606971686 |
| 230204199609291726@sjtu.edu.cn |
Public
No. 1954, Huashan Road
Shanghai
200030
China
| Phone | +86 (0)15606971686 |
|---|---|
| 230204199609291726@sjtu.edu.cn |
Study information
| Study design | Single-centre interventional open-label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Effects of ω-3 polyunsaturated fatty acid supplementation on depressive symptoms, cognition conditions and plasma metabolome in adolescent patients with depressive disorder |
| Study acronym | PUFA DD |
| Study hypothesis | The aim of this study is to evaluate the therapeutic effects of ω-3 polyunsaturated fatty acid (PUFA) supplementation combined with paroxetine in adolescent patients with depression, and explore whether niacin skin flushing response is related to depressive symptoms. |
| Ethics approval(s) | Approved 21/04/2020, Ethical Committee of the Fourth People's Hospital of Wuhu (No.1, Wuxiashan East Road, Wuhu City, Anhui Province, China; +86 (0)553 3028569; xiazhongxiansheng@163.com), ref: not applicable |
| Condition | Depressive disorder |
| Intervention | Patients are randomly assigned to take paroxetine alone (paroxetine group, n = 37) and ω-3 PUFA rich fish oil in addition to paroxetine (ω-3 PUFA + paroxetine group, n = 34) for 12 weeks, according to a computer-generated random sequence using block randomisation with random block sizes. The randomisation is performed by the independent statistician. Patients are enrolled and assigned sequentially to adjuvant interventions by the physician. The allocation sequence is not available to any member of the research team until the databases had been completed and locked. The dose of paroxetine is 20 mg per day and ω-3 PUFA rich fish oil is three capsules per day (providing 2700 mg of total ω-3 PUFA; 1941 mg EPA and 759 mg DHA, EPA:DHA ratio = 2.56:1). The severity of depressive symptoms, cognition and memory conditions are assessed by trained psychiatrists using the Montgomery-Asberg Depression Rating Scale (MADRS), Montreal Cognitive Assessment (MoCA) and Wisconsin Card Sorting Test (WCST), and Wechsler Memory Scale (WMS), respectively, before therapy (baseline), and at weeks 4, 8, and 12. Niacin skin flushing response is tested at the week 0, 4, 8 and 12. Blood samples are taken at weeks 0 and 12. |
| Intervention type | Supplement |
| Primary outcome measure | Depressive symptoms measured using the Montgomery-Osberg Depression Rating Scale (MADRS) at baseline, weeks 4, 8, and 12 |
| Secondary outcome measures | 1. Cognition conditions measured using Montreal Cognitive Assessment (MoCA) and Wisconsin Card Sorting Test (WCST) at baseline, weeks 4, 8, and 12 2. Memory conditions measured using Wechsler Memory Scale (WMS) at baseline, weeks 4, 8, and 12 3. Niacin skin flushing response test using six different concentrations (triple gradient dilution from 60 mM) of niacin dropped onto the skin at baseline, weeks 4, 8, and 12 4. Plasma metabolome measured using ultrahigh-performance liquid chromatography-quadrupole orbitrap mass spectrometry at baseline and week 12 5. Membrane lipids measured using gas chromatography mass spectrometry at baseline and week 12 |
| Overall study start date | 01/04/2020 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 71 = 37 in paroxetine group and 34 in ω-3 PUFA + paroxetine group |
| Total final enrolment | 66 |
| Participant inclusion criteria | Current inclusion criteria as of 30/08/2022: 1. Meet the diagnostic criteria of International Classification of Diseases (ICD-10) for depressive disorder 2. Aged 13-24 years 3. Never received antidepressant medication, or have not received antidepressant medication within 2 weeks 4. The patient's family members or legal guardians fully understood the content of this study and signed informed consent _____ Previous inclusion criteria: 1. The diagnostic criteria of International Classification of Diseases (ICD-10) for depressive disorder 2. 14-25 years old 3. Never received antidepressant medication, or have not received antidepressant medication within 2 weeks 4. The patient's family members or legal guardians fully understood the content of this study and signed informed consent |
| Participant exclusion criteria | 1. People diagnosed with bipolar disorder or other according to the ICD-10 2. A recent or past history of alcohol and drug dependence, other psychiatric disorders, eating disorders or mental retardation 3. Serious or chronic physical disease, endocrine disease or organic brain diseases 4. Regular consumption of ω-3 PUFA supplements or eating fish equal to or more than 4 times per week 5. Conducting additional clinical trials within 4 weeks prior to the start of this study |
| Recruitment start date | 29/11/2020 |
| Recruitment end date | 01/01/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Wuhu
241002
China
Sponsor information
University/education
No. 1954, Huashan Road
Shanghai
200030
China
| Phone | +86 (0)21 62833148 |
|---|---|
| wangjinfeng@sjtu.edu.cn | |
| Website | http://en.sjtu.edu.cn/ |
"ROR" |
https://ror.org/0220qvk04 |
Funders
Funder type
Government
No information available
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Shanghai Natural Science Foundation, Shanghai Municipal Natural Science Foundation, Shanghai Municipal Natural Science Fund, 上海市自然科学基金
- Location
- China
Government organisation / Universities (academic only)
- Alternative name(s)
- 上海交通大学, 上海交通大學, Nanyang Public School, Nan Yang College of Chiao Tung, National Chiao Tung University, Jiao Tong University, SJTU
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal: 1. Clinical symptoms - 2022 2. Niacin skin flushing test - 2022 3. Molecular experiments - 2025 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from 230204199609291726@sjtu.edu.cn and qingying@sjtu.edu.cn. The data will be available beginning 3 months and ending 5 years following article publication. It can be shared with researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. To gain access, data requesters will need to sign a data access agreement. Consent from participants was obtained. Data will be de-identified by removing personally identifiable information. |
Editorial Notes
30/08/2022: The following changes have been made:
1. The participant inclusion criteria have been changed.
2. The total final enrolment has been changed from 53 to 66.
3. The scientific contact's details have been updated.
10/03/2022: Trial's existence confirmed by the Ethical Committee of the Fourth People's Hospital of Wuhu.
