Phospholipid Hypothesis of Depression: From Molecular Biology, Neuroimaging to Behaviour
NCT ID: NCT02615405
Last Updated: 2015-11-26
Study Results
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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COMPLETED
NA
240 participants
INTERVENTIONAL
2012-08-31
2015-01-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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EPA
3.5 g/day in Studies 1 \& 2
EPA
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
DHA
A daily treatment of 5 identical capsules of DHA (1.75 g/d) for Studies 1 \& 2.
Placebo capsules
oleic oil in Study 1
Placebo
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.
DHA
A daily treatment of 5 identical capsules of DHA (1.75 g/d) for Studies 1 \& 2.
Placebo
A daily treatment of 5 identical capsules of placebo (high oleic oil) in single or divided administration for Study 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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National Science and Technology Council, Taiwan
OTHER_GOV
Responsible Party
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Kuan-Pin
China Medical University Hospital
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
Countries
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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.
Other Identifiers
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NSC101-2628-B-039-001-MY3
Identifier Type: -
Identifier Source: org_study_id