N-3 Polyunsaturated Fatty Acids in the Prevention and Treatment for IFN-induced Depression

Not Applicable

Completed

• Conditions: Major Depressive Episode
• Interventions: Dietary Supplement: Omega-3 fatty acids

• Registration Number: NCT01620502
• Lead Sponsor: National Science Council, Taiwan

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.

Detailed Description

We have done a preliminary analysis in 63 HCV patients receiving IFN-α therapy enrolled in our current NSC project (NSC95-2320-B-039-037-MY3) and found that patients who later developed IFN-α-induced depression (case group, 21/63) had lower PUFA levels before starting IFN-α therapy than control group (p=0.024). In addition, there was a trend for a negative correlation (r=-0.224; p=0.078) between baseline DHA levels and the highest scores of BDI during IFN therapy in the whole group. These findings indicate that n-3 PUFAs might play a protective factor.

This 3-year proposal is divided into 2 clinical studies. In study 1, we aim to test the prophylactic effect of n-3 PUFAs (EPA: 3.5 g/d and DHA: 1.75 g/d versus placebo: high oleic oil) for IFN-α-induced sickness behaviour and depressive symptoms, in a two-week, double-blind, placebo-controlled trial of 152 patients with HCV starting IFN-α therapy. In study 2, we will test the antidepressant effect of n-3 PUFAs (EPA: 3.5 g/d and DHA: 1.75 g/d versus placebo: high oleic oil) on IFN-α-induced depression during IFN-α therapy, in an eight-week, double-blind, placebo-controlled trial in 80 HCV patients who have already developed depression.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2012-06
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-15
• Study Completion: 2012-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-26
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPA 3.5 g/day	Omega-3 fatty acids	-
Placebo capsules	Omega-3 fatty acids	oleic oil
DHA 1.75 g/day	Omega-3 fatty acids	DHA 1.75 g/day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes in Hamilton Depression Rating Scale (HDRS) (for Study 1); Response and remission rates (for Study 2)	Weeks 0 to 24

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan