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The Effect of Fish Oil in Major Depressive Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01371383
First Posted: June 10, 2011
Last Update Posted: May 14, 2012
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.
Information provided by (Responsible Party):
Kuan-Pin, National Science Council, Taiwan
  Purpose
The first part is a double-blind placebo-controlled trial to identify the effects of omega-3 polyunsaturated fatty acids (PUFAs) monotherapy in depression. The second part is a double-blind trial to identify the effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on different symptom clusters in patients with depression.

Condition Intervention Phase
Major Depressive Disorder Dietary Supplement: Omega-3 fatty acids Dietary Supplement: placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Fish Oil in Major Depressive Disorder: a Double-blind Placebo-controlled Monotherapy Trail to Demonstrate the Therapeutic Effects of Depression

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Changes in Hamilton Depression Rating Scale (HDRS) [ Time Frame: Weeks 0 and 8 ]

Secondary Outcome Measures:
  • Changes in Beck Depression Inventory (BDI) [ Time Frame: Weeks 0 and 8 ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Weeks 0 and 8 ]

Enrollment: 120
Study Start Date: January 2005
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: omega-3 fatty acids Dietary Supplement: Omega-3 fatty acids
1.6~2.8 gram/day (5 capsules)
Other Name: DHA/EPA
Placebo Comparator: Placebo Dietary Supplement: placebo
5 gram/day (5 capsules)
Other Name: control

Detailed Description:

With the dissatisfaction of monoamine-based pharmacotherapy and the high comorbidity of physical illness in depression, the serotonin hypothesis seems to fail in approaching the etiology of depression. Based upon the evidence from epidemiological data, case-control studies of PUFAs levels in human tissues, and antidepressant effect in clinical trials, phospholipid PUFAs is enlightening a promising path to discover the unsolved of depression.

The PUFAs are classified into n-3 (or omega-3) and n-6 (or omega-6) groups. Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), the major bioactive components of n-3 PUFAs, are not synthesized in humans and can only be obtained directly from the diet, particularly by consuming fish. The deficit of n-3 PUFAs has been reported to be associated with neurological, cardiovascular, cerebrovascular, autoimmune, and metabolic diseases. Recent studies revealed that the deficit of n-3 PUFAs is also associated with depression. More specifically, societies that consume a small amount of omega-3 PUFAs appear to have a higher prevalence of major depressive disorder. In addition, depressive patients had showed a lower level of omega-3 PUFAs; and the antidepressant effect of PUFAs had been reported in a number of clinical trials. Theoretically, DHA deficit is associated with dysfunctions of neuronal membrane stability and transmission of serotonin, norepinephrine and dopamine, which might connect to etiology of depression. On the other hand, EPA is important in balancing the immune function by reducing membrane arachidonic acid (AA, an n-6 PUFA) and prostaglandin E2 (PGE2) synthesis. Interestingly, animals fed with high AA diet or treated with PGE2 present sickness behaviors of anorexia, low activity, change in sleep pattern and attention, which are similar to somatic symptoms of depression in human.

There are little data at this stage to reveal whether the oral administration of omega-3 fatty acids monotherapy would lead to an effective mood stabilization in major depressive disorder. In addition, the active component of antidepressant effect in n-3 PUFAs is still unknown. In this project, the first part is a double-blind placebo-controlled trial to identify the effects of omega-3 PUFAs monotherapy in depression. The second part is a double-blind trial to identify the effects of EPA and DHA on different symptom clusters in patients with depression.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DSM-IV criteria for major depressive disorder.
  2. Age being age 18-65.
  3. Capacity and willingness to give written informed consent.

Exclusion Criteria:

  1. Any major medical illnesses.
  2. A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder.
  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): NCT01371383


Locations
Taiwan
China Medical University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
National Science Council, Taiwan
Investigators
Principal Investigator: Kuan-Pin Su, MD PhD China Medical University Hospital
  More Information

Responsible Party: Kuan-Pin, China Medical University Hospital, National Science Council, Taiwan
ClinicalTrials.gov Identifier: NCT01371383     History of Changes
Other Study ID Numbers: DOH94F044
First Submitted: June 7, 2011
First Posted: June 10, 2011
Last Update Posted: May 14, 2012
Last Verified: May 2012

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