NCT02615405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

2.4 years

First QC Date

November 24, 2015

Last Update Submit

November 25, 2015

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (3)

  • Changes from Baseline Hamilton Depression Rating Scale (HDRS) at 12 weeks

    Week 12

  • Remission rate

    Week 12

  • Response rate

    Week 12

Secondary Outcomes (2)

  • Changes in Beck Depression Inventory (BDI)

    Week 12

  • Changes in Neurotoxicity Rating Scale (NRS)

    Week 12

Study Arms (3)

EPA

EXPERIMENTAL

3.5 g/day in Studies 1 \& 2

Dietary Supplement: EPA

DHA

ACTIVE COMPARATOR

1.75 g/day in Studies 1 \& 2

Dietary Supplement: DHA

Placebo capsules

PLACEBO COMPARATOR

oleic oil in Study 1

Dietary Supplement: Placebo

Interventions

EPADIETARY_SUPPLEMENT

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

Also known as: Fish oil EPA
EPA
DHADIETARY_SUPPLEMENT

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

Also known as: Fish oil DHA
DHA
PlaceboDIETARY_SUPPLEMENT

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

Also known as: oleic oil
Placebo capsules

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan, 403, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 28648567DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Kuan-Pin Su, MD PhD

    China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
China Medical University Hospital

Study Record Dates

First Submitted

November 24, 2015

First Posted

November 26, 2015

Study Start

August 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

November 26, 2015

Record last verified: 2015-11

Locations

TW(1)