Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE November 24, 2015
First Posted Date  ICMJE November 26, 2015
Last Update Posted Date November 26, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • Changes from Baseline Hamilton Depression Rating Scale (HDRS) at 12 weeks [ Time Frame: Week 12 ]
  • Remission rate [ Time Frame: Week 12 ]
  • Response rate [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • Changes in Beck Depression Inventory (BDI) [ Time Frame: Week 12 ]
  • Changes in Neurotoxicity Rating Scale (NRS) [ Time Frame: Week 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phospholipid Hypothesis of Depression: From Molecular Biology, Neuroimaging to Behaviour
Official Title  ICMJE Not Provided
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: EPA
    3.5 g/day in Studies 1 & 2
    Intervention: Dietary Supplement: EPA
  • Active Comparator: DHA
    1.75 g/day in Studies 1 & 2
    Intervention: Dietary Supplement: DHA
  • Placebo Comparator: Placebo capsules
    oleic oil in Study 1
    Intervention: Dietary Supplement: Placebo
Publications * Su KP, Yang HT, Chang JP, Shih YH, Guu TW, Kumaran SS, Gałecki P, Walczewska A, Pariante CM. Eicosapentaenoic and docosahexaenoic acids have different effects on peripheral phospholipase A2 gene expressions in acute depressed patients. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Jan 3;80(Pt C):227-233. doi: 10.1016/j.pnpbp.2017.06.020. Epub 2017 Jun 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2015)
240
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02615405
Other Study ID Numbers  ICMJE NSC101-2628-B-039-001-MY3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kuan-Pin, National Science Council, Taiwan
Study Sponsor  ICMJE National Science Council, Taiwan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kuan-Pin Su, MD PhD China Medical University Hospital
PRS Account National Science Council, Taiwan
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP