Depressive disorder Mental and Behavioural Disorders Depressive episode, unspecified
Conditions
Interventions
Patients are randomly assigned to take paroxetine alone (paroxetine group, n = 37) and ?-3 PUFA rich fish oil in addition to paroxetine (?-3 PUFA + paroxetine group, n = 34) for 12 weeks, according to
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-As
Sponsors
Shanghai Jiao Tong University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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 ?-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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive symptoms measured using the Montgomery-Osberg Depression Rating Scale (MADRS) at baseline, weeks 4, 8, and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Contacts
Public ContactShuhui Li
Outcome results
None listed