Major Depressive Disorder
Conditions
Keywords
Depression, omega-3 fatty acids, nutritional intervention
Brief summary
Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD.
Detailed description
In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.
Interventions
DIETARY_SUPPLEMENTOmega-3 fatty acids
12-week double-blind, randomized controlled trial
Sponsors
National Science and Technology Council, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* the diagnostic criteria of DSM-IV for MDD * 18 to 65 years old * pre-study ratings of 18 or greater on the 21-item Hamilton Rating Scale for Depression (HAMD) * physically healthy under comprehensive evaluations in medical history, physical examination, and laboratory parameters tests * have not received any psychiatric treatment in 2 weeks * competent to receive a full explanation of this study and give written informed consent.
Exclusion criteria
* a recent or past history of other DSM-IV AxisI diagnoses besides unipolar major depression, including psychotic disorders, organic mental disorders, impulse control disorders, substance use disorder or substance abuse (last 6 months prior to the study), and bipolar disorders * AxisII diagnoses, including borderline and antisocial personality disorder * a notable medical comorbidity * acutely suicidal ideation and attempt were noted that close monitoring such as hospitalization is necessary * regular consumption of omega-3 PUFAs supplements or a habit of eating fish equal or more than 4 times per week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Rating Scale for Depression (HAMD) Changes | From Week 0 to Week 12 | The Changes of scores in Hamilton Rating Scale for Depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remission rate | at Week 12 | Less than 8 points in the Hamilton Rating Scale for Depression at W12 |
| Response rate | at Week 12 | 50% decreases in the Hamilton Rating Scale for Depression from W0 to W12 |
Countries
Taiwan
Outcome results
None listed