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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01620502
Enrollment
230
Registered
2012-06-15
Start date
2009-07-31
Completion date
2012-09-30
Last updated
2013-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Episode

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.

Interventions

DIETARY_SUPPLEMENTOmega-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)

Sponsors

National Science and Technology Council, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026