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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01620502
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Major Depressive Episode Dietary Supplement: Omega-3 fatty acids

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: N-3 Polyunsaturated Fatty Acids in the Prevention and Treatment for IFN-induced Depression
Study Start Date : July 2009
Primary Completion Date : June 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Changes in Hamilton Depression Rating Scale (HDRS) (for Study 1); Response and remission rates (for Study 2) [ Time Frame: Weeks 0 to 24 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013

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