Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder: A Randomized Controlled TrialNCT03732378
Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder.
A study testing Omega-3 capsule in people with Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder: A Randomized Controlled Trial, run by Allama Iqbal Open University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder: A Randomized Controlled Trial
- What is being tested?
- Omega-3 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Apr 2017to 10 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient aged from 20 to 40 years age and taking anti-depressant drugs, were selected for study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder
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.
Read the 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.
- Being tested
- Omega-3 capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 capsuleDietary supplement
Daily one capsule of omega-3 (EPA 300mg, and 200mg DHA) were given anti depressent( citalopram, escitalopram, paroxetine 1 tablet at night time)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Dietary Supplement: Omega-3 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: half an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start27 Apr 2017
- Primary completion16 Aug 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder: A Randomized Controlled TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Open University Islamabad
- Sponsor type
- University, hospital or other
- Collaborators
- King Edward Medical University
- Responsible party
- Principal investigator, Naiza Yousef, Allama Iqbal Open University Islamabad
- Investigators
- Zaheer Ahmad, Phd, Study director, Allama Iqbal Open University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732378
- Sponsor's protocol ID
- 561/17
- Status last verified
- Nov 2018
- First submitted
- 31 Oct 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arnaud A, Gayrard P, Ohresser P. [Bronchomotor tonus: per-operative bronchospasm]. Ann Anesthesiol Fr. 1976;17(2):139-44. French.
PubMed 62529Appleton 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.
PubMed 34817851
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03732378
- Acronym / sponsor ID
- 561/17
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Allama Iqbal Open University IslamabadUniversity, hospital or other
- Collaborators
- King Edward Medical University
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Experimental | Dietary Supplement: Omega-3 capsuleone 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) |
| Placebo | Placebo comparator | Dietary Supplement: Omega-3 capsuleone 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient aged from 20 to 40 years age and taking anti-depressant drugs, were selected for study.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 capsuleDaily one capsule of omega-3 (EPA 300mg, and 200mg DHA) were given anti depressent( citalopram, escitalopram, paroxetine 1 tablet at night time) | Dietary supplement | Omega-3, Placebo |
Primary outcome
Beck depression inventory scale
Time frame: half an hour
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Background: PubMed 62529Arnaud A, Gayrard P, Ohresser P. [Bronchomotor tonus: per-operative bronchospasm]. Ann Anesthesiol Fr. 1976;17(2):139-44. French.
- Derived from this study: PubMed 34817851Appleton 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaheer Ahmad, Phd study director
Allama Iqbal Open University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 capsule in people with Role of Omega-3 Polyunsaturated Fatty Acid in the Management of Major Depressive Disorder: A Randomized Controlled Trial, run by Allama Iqbal Open University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck depression inventory scale (time frame: half an hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03732378, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.