Major Depressive Disorder Clinical Trial
Official title:
The Effect of Fish Oil in Major Depressive Disorder: a Double-blind Placebo-controlled Monotherapy Trail and a RCT for Recurrence Prevention
Verified date | April 2015 |
Source | National Science Council, Taiwan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medical University | Taichung |
Lead Sponsor | Collaborator |
---|---|
National Science Council, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HAMD | W0 W2 W4 W8 W12 | No | |
Secondary | BDI | W0 W2 W4 W8 W12 | No | |
Secondary | Adverse effects | W0 W2 W4 W8 W12 | Yes | |
Secondary | Recurrence rate | M0 M1 M2 M3 M4 M6 | No |
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