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

NCT ID: NCT02615405

Last Updated: 2015-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-01-31

Brief Summary

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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

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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).

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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EPA

3.5 g/day in Studies 1 \& 2

Group Type EXPERIMENTAL

EPA

Intervention Type DIETARY_SUPPLEMENT

A daily treatment of 5 identical capsules of EPA (3.5 g/d) for Studies 1 \& 2.

DHA

1.75 g/day in Studies 1 \& 2

Group Type ACTIVE_COMPARATOR

DHA

Intervention Type DIETARY_SUPPLEMENT

A daily treatment of 5 identical capsules of DHA (1.75 g/d) for Studies 1 \& 2.

Placebo capsules

oleic oil in Study 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

A daily treatment of 5 identical capsules of placebo (high oleic oil) in single or divided administration for Study 1.

Interventions

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EPA

A daily treatment of 5 identical capsules of EPA (3.5 g/d) for Studies 1 \& 2.

Intervention Type DIETARY_SUPPLEMENT

DHA

A daily treatment of 5 identical capsules of DHA (1.75 g/d) for Studies 1 \& 2.

Intervention Type DIETARY_SUPPLEMENT

Placebo

A daily treatment of 5 identical capsules of placebo (high oleic oil) in single or divided administration for Study 1.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fish oil EPA Fish oil DHA oleic oil

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kuan-Pin

China Medical University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuan-Pin Su, MD PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, Taiwan, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 28648567 (View on PubMed)

Other Identifiers

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NSC101-2628-B-039-001-MY3

Identifier Type: -

Identifier Source: org_study_id