Major DepressionPhase 3NCT00067301
PUFA Augmentation in Treatment of Major Depression
A Phase 3 study testing Polyunsaturated Fatty Acids (PUFA) and Citalopram in people with Major Depression, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to determine if omega-3 fatty acid EPA will enhance and speed up response to antidepressant therapy with Celexa (Citalopram) in people suffering from Major Depressive Disorder. All patients will receive Celexa, 50% will receive EPA, 50% placebo EPA. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Polyunsaturated Fatty Acids (PUFA) and Citalopram
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Apr 2007
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet DSM-IV criteria for current major depression, and have a HAM-D (21 item) score of > 17
- Male or female who, if of child-bearing potential, agrees to use effective contraception including the regular use of contraceptive pills, intra-uterine devices, barrier methods or abstinence
- Age between 18 and 65
- Capable of giving informed consent
Who cannot join
- Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders
- Current drug or alcohol abuse or dependence, or history of drug or alcohol abuse or dependence within the previous 6 months
- Unstable medical or neurological conditions that are likely to interfere with the treatment of depression
- History of allergy to citalopram or ProEPA, finfish or shellfish
- History of failure of response to citalopram, as documented by an adequate trial of the medication [defined as having been treated with the medication at a dose level typically regarded as adequate (i.e., 40 mg of citalopram per day) for at least 6 weeks]
- History of seizure disorder
Show all 12Show fewer
- Pregnancy
- Currently on psychotropic medications including antidepressants or neuroleptics
- Active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study
- Exposure to treatment with fluoxetine or MAOIs in the previous two months
- Patients on anticoagulant therapy
- Patients with a dietary intake of > 3.0g total omega-3 PUFA/day at baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center Dept. of Psychiatry
Los Angeles, California, 90048
About this study
The purpose of this study is to determine if omega-3 fatty acid EPA will enhance and speed up response to antidepressant therapy with Celexa (Citalopram) in people suffering from Major Depressive Disorder. All patients will receive Celexa, 50% will receive EPA, 50% placebo EPA.
Read the detailed description
As per brief summary
- Conditions
- Major Depression
- Being tested
- Polyunsaturated Fatty Acids (PUFA), Citalopram
- Keywords
- depression, citalopram, Celexa, Polyunsaturated Fatty Acids, omega-3, EPA, antidepressants
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyunsaturated Fatty Acids (PUFA)Drug
CitalopramDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2003 (estimated)
- Study startSep 2003
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Lev Gertsik, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067301
- Sponsor's protocol ID
- R21AT001077
- Other IDs
- GertsikL
- Status last verified
- Jan 2008
- First submitted
- 14 Aug 2003
- Last updated
- 25 Jan 2008
- Results posted
- No
Publications
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.
PubMed 34817851
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PUFA Augmentation in Treatment of Major Depression
- ClinicalTrials.gov ID
- NCT00067301
- Acronym / sponsor ID
- R21AT001077
- Conditions
- Major Depression
- Keywords
- depression, citalopram, Celexa, Polyunsaturated Fatty Acids, omega-3, EPA, antidepressants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Aug 2003 (estimated)
- 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.
The purpose of this study is to determine if omega-3 fatty acid EPA will enhance and speed up response to antidepressant therapy with Celexa (Citalopram) in people suffering from Major Depressive Disorder. All patients will receive Celexa, 50% will receive EPA, 50% placebo EPA.
Detailed description
As per brief summary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet DSM-IV criteria for current major depression, and have a HAM-D (21 item) score of > 17
- Male or female who, if of child-bearing potential, agrees to use effective contraception including the regular use of contraceptive pills, intra-uterine devices, barrier methods or abstinence
- Age between 18 and 65
- Capable of giving informed consent
Key exclusion criteria (12 listed)
- Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders
- Current drug or alcohol abuse or dependence, or history of drug or alcohol abuse or dependence within the previous 6 months
- Unstable medical or neurological conditions that are likely to interfere with the treatment of depression
- History of allergy to citalopram or ProEPA, finfish or shellfish
- History of failure of response to citalopram, as documented by an adequate trial of the medication [defined as having been treated with the medication at a dose level typically regarded as adequate (i.e., 40 mg of citalopram per day) for at least 6 weeks]
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 |
|---|---|---|
| Polyunsaturated Fatty Acids (PUFA) | Drug | – |
| Citalopram | Drug | – |
Primary outcome
Not reported in the source record.
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 25 Jan 2008.
- 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.
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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.
Lev Gertsik, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polyunsaturated Fatty Acids (PUFA) and Citalopram in people with Major Depression, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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 4 inclusion and 12 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 25 Jan 2008. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00067301, which also lists 1 linked publication.
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 25 Jan 2008.