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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kuan-Pin, National Science Council, Taiwan
ClinicalTrials.gov Identifier:
NCT01620502
First received: June 13, 2012
Last updated: October 26, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Major Depressive Episode
Dietary Supplement: Omega-3 fatty acids

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: N-3 Polyunsaturated Fatty Acids in the Prevention and Treatment for IFN-induced Depression

Resource links provided by NLM:


Further study details as provided by National Science Council, Taiwan:

Primary Outcome Measures:
  • Percentage of Participants with major depressive episode (for Study 1); Changes in Hamilton Depression Rating Scale (HDRS) (for Study 2) [ Time Frame: Weeks 0 to 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Hamilton Depression Rating Scale (HDRS) (for Study 1); Response and remission rates (for Study 2) [ Time Frame: Weeks 0 to 24 ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: July 2009
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EPA 3.5 g/day Dietary Supplement: 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)
Other Name: Omega-3 PUFAs or fish oil
Placebo Comparator: Placebo capsules
oleic oil
Dietary Supplement: 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)
Other Name: Omega-3 PUFAs or fish oil
Experimental: DHA 1.75 g/day
DHA 1.75 g/day
Dietary Supplement: 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)
Other Name: Omega-3 PUFAs or fish oil

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01620502

Locations
Taiwan
China Medical University Hospital
Taichung, Taiwan, 403
Sponsors and Collaborators
National Science Council, Taiwan
Investigators
Principal Investigator: Kuan-Pin Su, MD PhD China Medical University Hospital
  More Information

No publications provided

Responsible Party: Kuan-Pin, China Medical University Hospital, National Science Council, Taiwan
ClinicalTrials.gov Identifier: NCT01620502     History of Changes
Other Study ID Numbers: NSC98-2628-B-039-020-MY3
Study First Received: June 13, 2012
Last Updated: October 26, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 21, 2014