Major Depressive Episode
Conditions
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
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
Study design
Eligibility
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| Changes in Hamilton Depression Rating Scale (HDRS) (for Study 1); Response and remission rates (for Study 2) | Weeks 0 to 24 |
Countries
Taiwan