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

National Science Council, Taiwan

Status: Completed

Conditions: Major Depressive Episode

Treatments: Dietary Supplement: Omega-3 fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT01620502

NSC98-2628-B-039-020-MY3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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230 participants in 3 patient groups, including a placebo group

EPA 3.5 g/day

Active Comparator group

Treatment:

Dietary Supplement: Omega-3 fatty acids

Placebo capsules

Placebo Comparator group

Description:

oleic oil

Treatment:

Dietary Supplement: Omega-3 fatty acids

DHA 1.75 g/day

Experimental group

Description:

DHA 1.75 g/day

Treatment:

Dietary Supplement: Omega-3 fatty acids