Phospholipid Hypothesis of Depression: From Molecular Biology, Neuroimaging to Behaviour
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
EPA
DHA
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility 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.
Sites / Locations
- China Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
EPA
DHA
Placebo capsules
Arm Description
3.5 g/day in Studies 1 & 2
1.75 g/day in Studies 1 & 2
oleic oil in Study 1
Outcomes
Primary Outcome Measures
Changes from Baseline Hamilton Depression Rating Scale (HDRS) at 12 weeks
Remission rate
Response rate
Secondary Outcome Measures
Changes in Beck Depression Inventory (BDI)
Changes in Neurotoxicity Rating Scale (NRS)
Full Information
NCT ID
NCT02615405
First Posted
November 24, 2015
Last Updated
November 25, 2015
Sponsor
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02615405
Brief Title
Phospholipid Hypothesis of Depression: From Molecular Biology, Neuroimaging to Behaviour
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Science Council, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EPA
Arm Type
Experimental
Arm Description
3.5 g/day in Studies 1 & 2
Arm Title
DHA
Arm Type
Active Comparator
Arm Description
1.75 g/day in Studies 1 & 2
Arm Title
Placebo capsules
Arm Type
Placebo Comparator
Arm Description
oleic oil in Study 1
Intervention Type
Dietary Supplement
Intervention Name(s)
EPA
Other Intervention Name(s)
Fish oil EPA
Intervention Description
A daily treatment of 5 identical capsules of EPA (3.5 g/d) for Studies 1 & 2.
Intervention Type
Dietary Supplement
Intervention Name(s)
DHA
Other Intervention Name(s)
Fish oil DHA
Intervention Description
A daily treatment of 5 identical capsules of DHA (1.75 g/d) for Studies 1 & 2.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
oleic oil
Intervention Description
A daily treatment of 5 identical capsules of placebo (high oleic oil) in single or divided administration for Study 1.
Primary Outcome Measure Information:
Title
Changes from Baseline Hamilton Depression Rating Scale (HDRS) at 12 weeks
Time Frame
Week 12
Title
Remission rate
Time Frame
Week 12
Title
Response rate
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Changes in Beck Depression Inventory (BDI)
Time Frame
Week 12
Title
Changes in Neurotoxicity Rating Scale (NRS)
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuan-Pin Su, MD PhD
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
403
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
28648567
Citation
Su KP, Yang HT, Chang JP, Shih YH, Guu TW, Kumaran SS, Galecki 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.
Results Reference
derived
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Phospholipid Hypothesis of Depression: From Molecular Biology, Neuroimaging to Behaviour
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