Major Depressive Disorder
Conditions
Brief summary
The whole study was divided into two major parts: (A) the 12-week, double-blind, randomized controlled, parallel omega-3 fatty acid monotherapy study in 60 patients with mild to moderate major depressive disorder. (B) The double-blind, randomized controlled, parallel omega-3 fatty acid add-on prevention study in 60 patients with major depressive disorder in recovery status. The goals of this study were to examine the therapeutic and recurrence prevention effects of omega-3 fatty acids on major depressive disorder.
Interventions
DIETARY_SUPPLEMENTOmega-3 fatty acids
EPA 2.1 g/d+DHA 1.1 g/d
DIETARY_SUPPLEMENTPlacebo
high oleic oil
Sponsors
National Science and Technology Council, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. DSM-IV criteria for major depressive disorder. 2. Age being age 18-65. 3. Capacity and willingness to give written informed consent.
Exclusion criteria
1. Any major medical illnesses. 2. A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD | W0 W2 W4 W8 W12 |
Secondary
| Measure | Time frame |
|---|---|
| BDI | W0 W2 W4 W8 W12 |
| Adverse effects | W0 W2 W4 W8 W12 |
| Recurrence rate | M0 M1 M2 M3 M4 M6 |
Countries
Taiwan
Outcome results
None listed