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Phospholipid Hypothesis of Depression: From Molecular Biology, Neuroimaging to Behaviour

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: NCT02615405
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : November 26, 2015
Sponsor:
Information provided by (Responsible Party):
Kuan-Pin, National Science Council, Taiwan

Brief Summary:
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 compositions, and antidepressant effects in clinical trials, phospholipid polyunsaturated fatty acids (PUFAs) is enlightening a promising path to discover the unsolved of depression.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Dietary Supplement: EPA Dietary Supplement: DHA Dietary Supplement: Placebo Not Applicable

Detailed Description:

There are several important questions to answer regarding phospholipid polyunsaturated fatty acids (PUFAs) hypothesis of depression. Firstly, although case-control studies revealed that depressive patients had lower levels of omega-3 PUFAs, the abnormal findings in individual PUFA of docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) or arachidonic acid (AA) are not consistent. Secondly, the deficits in n-3 PUFAs are related to their metabolic enzymes. However, the association study of polymorphisms of PUFA-metabolism related genes in depression is limited. Thirdly, the active component of antidepressant effect in n-3 PUFAs is still in debate. Fourthly, the molecular mechanisms of n-3 PUFAs' antidepressant effects have yet to be elucidated in human brain functional neuroimaging or in cellular models.

This 3-year proposal is divided into 2 clinical studies. In study 1, the investigators aim to test the clinical and biological effects of n-3 PUFAs (EPA: 3.5 g/d and DHA: 1.75 g/d versus placebo: high oleic oil) for depressive symptoms in a 12-week, double-blind, placebo-controlled trial of patients with drug-free MDD. In study 2, the investigators will measure the biological and neuroimaging markers to investigate the biological mechanisms of EPA (3.5 g/d) versus DHA (1.75 g/d) in 12-week, double-blind, randomized-controlled trial with patients with drug-free major depression disorder (MDD).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EPA
3.5 g/day in Studies 1 & 2
Dietary Supplement: EPA
A daily treatment of 5 identical capsules of EPA (3.5 g/d) for Studies 1 & 2.
Other Name: Fish oil EPA

Active Comparator: DHA
1.75 g/day in Studies 1 & 2
Dietary Supplement: DHA
A daily treatment of 5 identical capsules of DHA (1.75 g/d) for Studies 1 & 2.
Other Name: Fish oil DHA

Placebo Comparator: Placebo capsules
oleic oil in Study 1
Dietary Supplement: Placebo
A daily treatment of 5 identical capsules of placebo (high oleic oil) in single or divided administration for Study 1.
Other Name: oleic oil




Primary Outcome Measures :
  1. Changes from Baseline Hamilton Depression Rating Scale (HDRS) at 12 weeks [ Time Frame: Week 12 ]
  2. Remission rate [ Time Frame: Week 12 ]
  3. Response rate [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Changes in Beck Depression Inventory (BDI) [ Time Frame: Week 12 ]
  2. Changes in Neurotoxicity Rating Scale (NRS) [ Time Frame: Week 12 ]


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

Inclusion Criteria:

  • Diagnostic and Statistical Manual (DSM)-IV criteria for major depressive disorder
  • Age being age 18-65.
  • Capacity and willingness to give written informed consent.
  • Free from antidepressants, mood stabilizers, and antipsychotics for more than 4 weeks.

Exclusion Criteria:

  • Any major medical illnesses.
  • 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.

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): NCT02615405


Locations
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Taiwan
China Medical University Hospital
Taichung, Taiwan, 403
Sponsors and Collaborators
National Science Council, Taiwan
Investigators
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Principal Investigator: Kuan-Pin Su, MD PhD China Medical University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kuan-Pin, China Medical University Hospital, National Science Council, Taiwan
ClinicalTrials.gov Identifier: NCT02615405    
Other Study ID Numbers: NSC101-2628-B-039-001-MY3
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders