Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder.

NCT03732378 | Completed

• 1 other identifier: 561/17
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Patients with major depressive disorder have prominently been reported to be related with subnormal polyunsaturated omega-3 fatty acids levels, importantly low docosahexaenoic acid and eicosapentaenoic acid in plasma and dietary intake. However, more randomized controlled trials are needed to support its importance in management of depression. Objective: To explore polyunsaturated omega-3 fatty acid role in major depressive disorder management. Materials \& Methods: Seventy patients 20 to 40 yeas, who were already diagnosed with depression and taking antidepressant treatment, were selected at department of psychiatry and behavioral sciences Kind Edward Medical University Lahore, and assigned into 2 groups, i.e. Intervention and control, by simple random lottery method. For twelve weeks, intervention group advised to take one omega-3 (300mg EPA, eicosapentaenoic acid and 200mg DHA docosahexaenoic acid), or placebo (500 mg corn oil) capsules once daily with meal. Beck Depression Inventory (BDI) scale was used to assess the depression. Demographic information was collected by using a structured questionnaire.

Conditions

Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder: A Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Beck depression inventory scale

  Normal ups down (1-10) Mild mood disturbance (11-16) Borderline clinical depression (17-20) Moderate depression (21-30) Severe depression (31-40) Extreme depression (over 40)

  half an hour

Study Arms (2)

Omega-3

EXPERIMENTAL

one capsule of omega-3 (EPA 300mg, and 200mg DHA) were given to treatment group along with already taking anti depressant drugs( citalopram, escitalopram, paroxetine 1 tablet at night time)

Dietary Supplement: Omega-3 capsule

Placebo

PLACEBO COMPARATOR

one capsule of 500 mg corn oil, along with already taking anti depressant drugs( citalopram, escitalopram, paroxetine 1 tablet at night time) were given to placebo group

Dietary Supplement: Omega-3 capsule

Interventions

Omega-3 capsule DIETARY_SUPPLEMENT

Daily one capsule of omega-3 (EPA 300mg, and 200mg DHA) were given anti depressent( citalopram, escitalopram, paroxetine 1 tablet at night time)

Omega-3; Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient aged from 20 to 40 years age and taking anti-depressant drugs, were selected for study.

You may not qualify if:

• Pregnant and lactating women and patients with history of allergy to omega-3 fatty acids shellfish were excluded.
• Patients with Serious neurological and medical conditions that can likely to interfere with the treatment of depression such as dementia, schizophrenia, epilepsy were also excluded.

Sponsors & Collaborators

• Allama Iqbal Open University Islamabad: lead
• King Edward Medical University: collaborator

Study Sites (1)

Zaheer Ahmad

Islamabad, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

• Arnaud A, Gayrard P, Ohresser P. [Bronchomotor tonus: per-operative bronchospasm]. Ann Anesthesiol Fr. 1976;17(2):139-44. French.

  PMID: 62529 BACKGROUND

• Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.

  PMID: 34817851 DERIVED

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Zaheer Ahmad, Phd

  Allama Iqbal Open University Islamabad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Along with anti psychotics, one capsule of omega-3 (EPA 300mg, and 200mg DHA) were given to treatment group , and 500 mg corn oil one capsules daily along with anti psychotics were given to placebo group. Patients were unaware about treatment and placebo as plastic transparent same packing was used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutritionist

Model Details: 12 week Randomized, single blind, placebo-Controlled Trial (RCT) was conducted at King Edward medical university, psychiatry \& behavioral sciences department Lahore. one capsule of omega-3 (EPA 300mg, and 200mg DHA) were given, or placebo (500 mg corn oil).

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 6, 2018
• Study Start: April 27, 2017
• Primary Completion: August 16, 2017
• Study Completion: November 10, 2017
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

PA (1)