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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Omega-3 capsule
Sponsored by
Allama Iqbal Open University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder: A Randomized Controlled Trial

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

  • Zaheer Ahmad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega-3

Placebo

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 31, 2018
Last Updated
November 5, 2018
Sponsor
Allama Iqbal Open University Islamabad
Collaborators
King Edward Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03732378
Brief Title
Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder.
Official Title
Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 27, 2017 (Actual)
Primary Completion Date
August 16, 2017 (Actual)
Study Completion Date
November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allama Iqbal Open University Islamabad
Collaborators
King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Study Design: 12 week Randomized, single blind, placebo-Controlled Trial (RCT) was conducted at King Edward medical university, psychiatry & behavioral sciences department Lahore. From 19 May 2017 to 16 August 2017 one capsule of omega-3 (EPA 300mg, and 200mg DHA) were given (38, 39), or placebo (500 mg corn oil) (40). Data Collection and Evaluation: Subjects were assessed at the first visit according to inclusion and exclusion criteria. Information about demographics, dietary habits and risk factors such as age, gender, height, weight and family history of depression, dietary habits, education levels, marital status, cigarette smoking, supplementation and sleeping hours were obtained by using a structured questionnaire in face to face interview in local and easy to understand language. BMI was calculated by using the equation BMI=kg/m2. Ethical Approval: Written approval (Reg.No.Psy/561/17) was taken from the head of psychiatry & behavioral sciences department, King Edward medical university Lahore. Informed consent had been taken from all study participants in written form after explaining the procedure of the study. Guidelines laid out in the Declaration of Helsinki were followed to conduct this study. Statistical Analysis: Data was analyzed through SPSS 20.0 with 95% confidence interval. Frequency distribution and of demographic variables were checked. Chi square test was used to check the relationship between depression and risk factors. Paired T test was used to analyze the before and after intervention mean difference. Results were presented in tabular and graphical form.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder: A Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 capsule
Intervention Description
Daily one capsule of omega-3 (EPA 300mg, and 200mg DHA) were given anti depressent( citalopram, escitalopram, paroxetine 1 tablet at night time)
Primary Outcome Measure Information:
Title
Beck depression inventory scale
Description
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)
Time Frame
half an hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient aged from 20 to 40 years age and taking anti-depressant drugs, were selected for study. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaheer Ahmad, Phd
Organizational Affiliation
Allama Iqbal Open University Islamabad
Official's Role
Study Director
Facility Information:
Facility Name
Zaheer Ahmad
City
Islamabad
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
62529
Citation
Arnaud A, Gayrard P, Ohresser P. [Bronchomotor tonus: per-operative bronchospasm]. Ann Anesthesiol Fr. 1976;17(2):139-44. French.
Results Reference
background
PubMed Identifier
34817851
Citation
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.
Results Reference
derived

Learn more about this trial

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

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