Fang 2019.
Study name | Study on the effect of PRKCB1 modulating inflammatory factors and the role for developing major depressive disorder |
Methods | Randomised placebo‐controlled trial |
Participants | Participants: Drug‐naïve or medication‐free for no less than 4 weeks; 18 ‐ 60 years old, Han nationality;
junior high school diploma or above; meeting the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)‐IV‐TR; Scored 17 or higher on the Hamilton's Depression Scale with 17 items (HAMD‐17) and scored 2 or higher for the 2nd item (depressive mood);
Written informed consent has been obtained Aiming to enrol 350 participants |
Interventions | Intervention: EPA ‐ 180 mg, DHA ‐ 120 mg, plus escitalopram ‐ 10 ‐ 20 mg/d Comparator: escitalopram ‐ 10 ‐ 20 mg/d |
Outcomes | Primary: remission of acute phase (HDRS score of 7 or less) at week 12, remission of consolidate or maintenance phase (HDRS score of 7 or less) at 12 months |
Starting date | January 2019 |
Contact information | Yiru Fang Fang, MD. PhD. Shanghai Mental Health Center, China |
Notes | Clinical Trials: ID: NCT03899194 |