N-3 Polyunsaturated Fatty Acids in the Prevention and Treatment for IFN-induced Depression
1 other identifier
interventional
230
1 country
1
Brief Summary
The first part is a double-blind placebo-controlled trial to identify the effects of omega-3 polyunsaturated fatty acids (PUFAs) in prevention of IFN-induced depression. The second part is a double-blind trial to identify the antidepressant effects of omega-3 PUFAs in patients with IFN-induced depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 13, 2012
CompletedFirst Posted
Study publicly available on registry
June 15, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedOctober 29, 2013
October 1, 2013
2.9 years
June 13, 2012
October 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with major depressive episode (for Study 1); Changes in Hamilton Depression Rating Scale (HDRS) (for Study 2)
Weeks 0 to 24
Secondary Outcomes (1)
Changes in Hamilton Depression Rating Scale (HDRS) (for Study 1); Response and remission rates (for Study 2)
Weeks 0 to 24
Study Arms (3)
EPA 3.5 g/day
ACTIVE COMPARATORPlacebo capsules
PLACEBO COMPARATORoleic oil
DHA 1.75 g/day
EXPERIMENTALDHA 1.75 g/day
Interventions
A daily treatment of 5 identical capsules of EPA (3.5 g/d), DHA (1.75 g/d) or placebo (high oleic oil), in single or divided administration for 2 (Study 1) or 8 weeks (Study 2)
Eligibility Criteria
You may qualify if:
- Eligible participants will be adult patients with chronic HCV, assessed by hepatologists and then referred for IFN-α therapy and have capacity and willingness to give written informed consent
You may not qualify if:
- Patients will be excluded if they have major depressive episode at assessment
- Any history of pre-existing psychotic disorders (e.g. schizophrenia or bipolar disorder)
- Alcohol or drug dependence within one year before entry into the study
- Seizure disorders and evidence of any unstable substantial coexisting medical conditions (e.g. cardiovascular, endocrine, haematological, renal, or neurological diseases)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 403, Taiwan
Related Publications (1)
Su KP, Lai HC, Yang HT, Su WP, Peng CY, Chang JP, Chang HC, Pariante CM. Omega-3 fatty acids in the prevention of interferon-alpha-induced depression: results from a randomized, controlled trial. Biol Psychiatry. 2014 Oct 1;76(7):559-66. doi: 10.1016/j.biopsych.2014.01.008. Epub 2014 Jan 24.
PMID: 24602409DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kuan-Pin Su, MD PhD
China Medical University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- China Medical University Hospital
Study Record Dates
First Submitted
June 13, 2012
First Posted
June 15, 2012
Study Start
July 1, 2009
Primary Completion
June 1, 2012
Study Completion
September 1, 2012
Last Updated
October 29, 2013
Record last verified: 2013-10