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

NCT ID: NCT01620502

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Major Depressive Episode

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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EPA 3.5 g/day

Group Type ACTIVE_COMPARATOR

Omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

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)

Placebo capsules

oleic oil

Group Type PLACEBO_COMPARATOR

Omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

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)

DHA 1.75 g/day

DHA 1.75 g/day

Group Type EXPERIMENTAL

Omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

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)

Interventions

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Omega-3 fatty acids

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)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Omega-3 PUFAs or fish oil

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kuan-Pin

China Medical University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuan-Pin Su, MD PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 24602409 (View on PubMed)

Other Identifiers

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NSC98-2628-B-039-020-MY3

Identifier Type: -

Identifier Source: org_study_id